U.S. patent application number 15/707197 was filed with the patent office on 2018-05-24 for advanced electrode array insertion with conditioning.
The applicant listed for this patent is Christopher Bennett, D. Juan Carlos Falcon Gonzalez, ngel Manuel Ramos Macias, ngel Ramos de Miguel, Sr., Riaan Rottier. Invention is credited to Christopher Bennett, D. Juan Carlos Falcon Gonzalez, ngel Manuel Ramos Macias, ngel Ramos de Miguel, Sr., Riaan Rottier.
Application Number | 20180140829 15/707197 |
Document ID | / |
Family ID | 60115862 |
Filed Date | 2018-05-24 |
United States Patent
Application |
20180140829 |
Kind Code |
A1 |
Ramos de Miguel, Sr.; ngel ;
et al. |
May 24, 2018 |
ADVANCED ELECTRODE ARRAY INSERTION WITH CONDITIONING
Abstract
A method, including obtaining information indicative of a
phenomenon sensed at a read electrode of a cochlear implant
electrode array relative to a reference and/or at a read electrode
remote from the electrode array relative to a reference, where one
of the electrodes of the cochlear implant electrode array was
energized executing a first analysis of the information to identify
one or more first meanings from among a first group of meanings of
the sensed phenomenon, conditioning the obtained information based
on the identified one or more first meanings, and executing a
second analysis of the conditioned information to identify one or
more second meanings from among a second group of meanings of the
sensed phenomenon.
Inventors: |
Ramos de Miguel, Sr.; ngel;
(Las Palmas, ES) ; Macias; ngel Manuel Ramos; (Las
Palmas, ES) ; Gonzalez; D. Juan Carlos Falcon; (Las
Palmas, ES) ; Rottier; Riaan; (Macquarie University,
AU) ; Bennett; Christopher; (Macquarie Park,
AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ramos de Miguel, Sr.; ngel
Macias; ngel Manuel Ramos
Gonzalez; D. Juan Carlos Falcon
Rottier; Riaan
Bennett; Christopher |
Las Palmas
Las Palmas
Las Palmas
Macquarie University
Macquarie Park |
|
ES
ES
ES
AU
AU |
|
|
Family ID: |
60115862 |
Appl. No.: |
15/707197 |
Filed: |
September 18, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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PCT/ES2017/000049 |
Apr 19, 2017 |
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15707197 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36038 20170801;
A61N 1/0541 20130101; A61N 1/08 20130101; G16H 50/20 20180101; G16H
20/30 20180101; G16H 40/63 20180101; A61N 1/37252 20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61N 1/08 20060101 A61N001/08; A61N 1/372 20060101
A61N001/372; A61N 1/36 20060101 A61N001/36 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 21, 2016 |
ES |
P201600344 |
Claims
1. A method, comprising: obtaining information indicative of a
phenomenon sensed at, at least one read electrode relative to at
least one reference of a cochlear implant electrode array and/or at
a read electrode remote from the electrode array relative to a
reference where at least one of the electrodes of the cochlear
implant electrode array was energized; executing a first analysis
of the information to identify one or more first meanings from
among a first group of meanings of the sensed phenomenon;
conditioning the obtained information based on the identified one
or more first meanings; and executing a second analysis of the
conditioned information to identify one or more second meanings
from among a second group of meanings of the sensed phenomenon.
2. The method of claim 1, wherein: the one or more second meanings
relates to a feature that impacts the conduction of electricity
globally relative to the electrode array.
3. The method of claim 1, further comprising: providing a virtual
indication to a healthcare professional that a dislocation or a
fold over of the electrode array has occurred and the location
thereof based on the second analysis.
4. The method of claim 1, wherein: the one or more second meanings
relates to a feature that is identifiable only if a specific
electrode is known of a plurality of potential intracochlear
sources of current corresponding to respective electrodes of the
cochlear array supplies current to the one or more read
electrodes.
5. The method of claim 1, wherein: the one or more second meanings
corresponds to an electrical phenomenon that will only change with
further movement of the electrode array in the cochlea, all other
things being equal.
6. The method of claim 1, wherein: the first group of meanings
includes least one of an open circuit, a short circuit, a shunt
circuit, a bubble proximate the electrode array, an electrode not
in the cochlea, an electrode conditioning phenomenon or a
phenomenon associated with a geometric property of a cochlea; and
second group of meanings includes at least one of fold over,
dislocation, bowing or electrode array misplacement.
7. The method of claim 1, wherein: the phenomenon sensed at the one
or more read electrodes was sensed at least one of while the
electrode array was being inserted into the cochlea or before the
electrode array was inserted into the cochlea.
8. (canceled)
9. A method, comprising: commencing insertion of a cochlear
electrode array into a cochlea of a person; establishing a source
and sink of electrical current in the recipient, wherein the source
is one of an energized stimulation electrode of the electrode array
that is located inside the cochlea or an energized electrode remote
from the electrode array; reading at least one read electrode,
relative to at least one reference, that received an electrical
signal from the energized stimulation electrode; and determining,
based on the reading, that a physical characteristic associated
with the electrode array that is strictly local to the electrode
array existed and/or exists.
10. The method of claim 9, wherein the physical characteristic is a
temporally static characteristic related to the physical condition
of the electrode array.
11. The method of claim 9, wherein the physical characteristic is a
temporally dynamic characteristic related to the local position of
the electrode array.
12. The method of claim 9, further comprising: after the
determining action, adjusting a location of the electrode array in
the cochlea and executing a second reading of a read electrode,
relative to a reference, or of another read electrode of the
electrode array, relative to a reference; and determining, based on
the second reading, that the physical characteristic associated
with the electrode array has changed.
13. The method of claim 9, further comprising: obtaining
information relating to an electrical phenomenon continuity pattern
of the electrode array, wherein the action of determining is based
on a determination that the reading is an abnormal reading relative
to the obtained electrical phenomenon continuity pattern.
14. The method of claim 9, further comprising: reading other read
electrodes relative to reference(s) that received the electrical
signal from the energized stimulation electrode; and identifying a
continuity electrical phenomenon associated with the electrodes
that were read, wherein the action of determining is based on a
determination that the reading is an abnormal reading relative to
the identified continuity electrical phenomenon.
15. The method of claim 9, wherein the physical characteristic is a
temporally static characteristic related to the physical condition
of the electrode array, and wherein the method further comprising:
second energizing a stimulation electrode of the electrode array
that is located inside the cochlea or an electrode remote from the
electrode array; second reading a read electrode relative to a
reference that received an electrical signal from the energized
stimulation electrode, wherein the read electrode is part of the
electrode array if the energized stimulation electrode is an
electrode remote from the electrode array; and determining, based
on the second reading, that the physical characteristic associated
with the electrode array that is strictly local to the electrode
array no longer exists.
16-24. (canceled)
25. A system, comprising: a control unit configured to receive
telemetry from an implantable system of a cochlear implant
electrode array and determine a feature related to a global
position of the electrode array relative to an interior of the
cochlea of the recipient, wherein the telemetry includes data based
on electrical phenomenon associated with the electrode array, the
control unit is further configured to automatically analyze the
data to determine whether or not portions of the data are
acceptable for use in determining the feature, and the control unit
is configured to automatically modify the data to at least one of
eliminate or replace the portions of the data that are deemed not
acceptable for use in determining the feature, and use the modified
data to determine the feature related to the global position of the
electrode.
26. The system of claim 25, wherein: the control unit is configured
to provide output that enables a virtual indication of the feature
to a healthcare professional proximate the cochlear implant
electrode array while the healthcare professional has direct access
to the implantable system.
27. The system of claim 25, wherein: the feature is an array fold
over of the cochlear electrode array; and the control unit is
configured to provide an indication of the occurrence of the fold
over of the cochlear electrode array while the healthcare
professional has direct access to the implantable system.
28. The system of claim 25, wherein: the feature is an array fold
over of the cochlear electrode array; and the control unit is
configured to provide an indication of the location of the fold
over of the cochlear electrode array while the healthcare
professional has direct access to the implantable system.
29. The system of claim 25, wherein: the system is configured to
provide the indication at a rate that is statistically more
reliable than a single X-ray of the cochlear of the recipient with
the electrode array therein.
30. The system of claim 25, wherein: the control unit is further
configured to automatically analyze the data to determine whether
or not portions of the data are indicative of an open circuit, a
short circuit, a bubble proximate the electrode array, an electrode
not in the cochlea, an electrode conditioning phenomenon or a
cochlea narrowing phenomenon, and deem the data unacceptable for
use if the data is indicative thereof.
31. (canceled)
Description
BACKGROUND
[0001] Hearing loss, which may be due to many different causes, is
generally of two types: conductive and sensorineural. Sensorineural
hearing loss is due to the absence or destruction of the hair cells
in the cochlea that transduce sound signals into nerve impulses.
Various hearing prostheses are commercially available to provide
individuals suffering from sensorineural hearing loss with the
ability to perceive sound. One example of a hearing prosthesis is a
cochlear implant.
[0002] Conductive hearing loss occurs when the normal mechanical
pathways that provide sound to hair cells in the cochlea are
impeded, for example, by damage to the ossicular chain or the ear
canal. Individuals suffering from conductive hearing loss may
retain some form of residual hearing because the hair cells in the
cochlea may remain undamaged.
[0003] Individuals suffering from hearing loss typically receive an
acoustic hearing aid. Conventional hearing aids rely on principles
of air conduction to transmit acoustic signals to the cochlea. In
particular, a hearing aid typically uses an arrangement positioned
in the recipient's ear canal or on the outer ear to amplify a sound
received by the outer ear of the recipient. This amplified sound
reaches the cochlea causing motion of the perilymph and stimulation
of the auditory nerve. Cases of conductive hearing loss typically
are treated by means of bone conduction hearing aids. In contrast
to conventional hearing aids, these devices use a mechanical
actuator that is coupled to the skull bone to apply the amplified
sound.
[0004] In contrast to hearing aids, which rely primarily on the
principles of air conduction, certain types of hearing prostheses
commonly referred to as cochlear implants convert a received sound
into electrical stimulation. The electrical stimulation is applied
to the cochlea, which results in the perception of the received
sound.
[0005] It is noted that in at least some instances, there is
utilitarian value to fitting a hearing prosthesis to a particular
recipient. In some examples of some fitting regimes, there are
methods which entail a clinician or some other professional
presenting sounds to a recipient of the hearing prosthesis such
that the hearing prosthesis evokes a hearing percept. Information
can be obtained from the recipient regarding the character of the
resulting hearing percept. Based on this information, the clinician
can adjust or otherwise establish settings of the hearing
prosthesis such that the hearing prosthesis operates according to
these settings during normal use.
[0006] It is also noted that the electrode array of the cochlear
implant generally shows utilitarian results if it is inserted in a
cochlea.
SUMMARY
[0007] In accordance with an exemplary embodiment, there is a
method, comprising obtaining information indicative of a phenomenon
sensed at a read electrode of a cochlear implant electrode array
relative to a reference and/or at a read electrode remote from the
electrode array relative to a reference where one of the electrodes
of the cochlear implant electrode array was energized, executing a
first analysis of the information to identify one or more first
meanings from among a first group of meanings of the sensed
phenomenon, conditioning the obtained information based on the
identified one or more first meanings, and executing a second
analysis of the conditioned information to identify one or more
second meanings from among a second group of meanings of the sensed
phenomenon.
[0008] In another exemplary embodiment, there is a method,
comprising, commencing insertion of a cochlear electrode array into
a cochlea of a person, energizing at least one stimulation
electrode of the electrode array that is located inside the cochlea
and/or an electrode remote from the electrode array; reading a read
electrode, relative to a reference, that received an electrical
signal from the energized stimulation electrode, and determining,
based on the reading, that a physical characteristic associated
with the electrode array that is strictly local to the electrode
array existed and/or exists
[0009] In another embodiment, there is a method, comprising (i)
obtaining information indicative of a phenomenon sensed at a read
electrode of a cochlear implant electrode array, relative to a
reference; and (ii) using that information to determine whether or
not a deleterious cochlear electrode array position exists inside
the cochlea of a recipient, wherein the actions used to make the
determination correspond to a statistical based accuracy rating of
at least 90 out of 100 vis-a-vis determinations that a deleterious
cochlear electrode array position exists.
[0010] In another embodiment, there is a system, comprising a
control unit configured to receive telemetry from an implantable
system of a cochlear implant electrode array and determine a
feature related to a global position of the electrode array
relative to an interior of the cochlea of the recipient, wherein
the telemetry includes data based on electrical phenomenon
associated with the electrode array, the control unit is further
configured to automatically analyze the data to determine whether
or not portions of the data are acceptable for use in determining
the feature, and the control unit is configured to automatically
modify the data to at least one of eliminate or replace the
portions of the data that are deemed not acceptable for use in
determining the feature, and use the modified data to determine the
feature related to the global position of the electrode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Embodiments are described below with reference to the
attached drawings, in which:
[0012] FIG. 1 is a perspective view of an exemplary hearing
prosthesis in which at least some of the teachings detailed herein
are applicable;
[0013] FIGS. 2A and 2B are side views of an embodiment of an
insertion guide for implanting a cochlear implant electrode
assembly such as the electrode assembly illustrated in FIG. 1;
[0014] FIGS. 3A and 3B are side and perspective views of an
electrode assembly extended out of an embodiment of an insertion
sheath of the insertion guide illustrated in FIG. 2;
[0015] FIGS. 4A-4E are simplified side views depicting the position
and orientation of a cochlear implant electrode assembly insertion
guide tube relative to the cochlea at each of a series of
successive moments during an exemplary implantation of the
electrode assembly into the cochlea;
[0016] FIG. 5A is a side view of a perimodiolar electrode assembly
partially extended out of a conventional insertion guide tube
showing how the assembly may twist while in the guide tube;
[0017] FIGS. 5B-5I are cross-sectional views of the electrode
assembly illustrated in FIG. 5A;
[0018] FIGS. 6A and 6B are views of an embodiment of the insertion
guide tube;
[0019] FIGS. 6C and 6D are views of an exemplary electrode array
and such located in the insertion guide tube;
[0020] FIG. 7 is an exemplary flowchart for an exemplary
method;
[0021] FIGS. 8-16 present some exemplary graphics associated with
some exemplary insertion regimes;
[0022] FIGS. 17-27 present some exemplary flowcharts for some
exemplary methods;
[0023] FIGS. 28-30 present some exemplary graphics associated with
some exemplary insertion regimes;
[0024] FIGS. 31-33 present some exemplary flowcharts for some
exemplary methods;
[0025] FIGS. 34-37 present some exemplary graphics associated with
some exemplary insertion regimes;
[0026] FIG. 38 presents some statistical data;
[0027] FIGS. 39A-39F present some exemplary graphics associated
with some exemplary insertion regimes; and
[0028] FIGS. 40-77 present some exemplary embodiments of hardware
for implementing some of the teachings detailed herein.
DETAILED DESCRIPTION
[0029] FIG. 1 is a perspective view of an exemplary cochlear
implant 100 implanted in a recipient having an outer ear 101, a
middle ear 105, and an inner ear 107. In a fully functional ear,
outer ear 101 comprises an auricle 110 and an ear canal 102.
Acoustic pressure or sound waves 103 are collected by auricle 110
and channeled into and through ear canal 102. Disposed across the
distal end of ear canal 102 is a tympanic membrane 104 that
vibrates in response to sound waves 103. This vibration is coupled
to oval window or fenestra ovalis 112 through the three bones of
the middle ear 105, collectively referred to as the ossicles 106,
and comprising the malleus 108, the incus 109, and the stapes 111.
Ossicles 106 filter and amplify the vibrations delivered by
tympanic membrane 104, causing oval window 112 to articulate, or
vibrate. This vibration sets up waves of fluid motion of the
perilymph within cochlea 140. Such fluid motion, in turn, activates
hair cells (not shown) inside the cochlea which in turn causes
nerve impulses to be generated which are transferred through spiral
ganglion cells (not shown) and auditory nerve 114 to the brain
(also not shown) where they are perceived as sound.
[0030] The exemplary cochlear implant illustrated in FIG. 1 is a
partially implanted stimulating medical device. Specifically,
cochlear implant 100 comprises external components 142 attached to
the body of the recipient, and internal or implantable components
144 implanted in the recipient. External components 142 typically
comprise one or more sound input elements for detecting sound, such
as microphone 124, a sound processor (not shown), and a power
source (not shown). Collectively, these components are housed in a
behind-the-ear (BTE) device 126 in the example depicted in FIG. 1.
External components 142 also include a transmitter unit 128
comprising an external coil 130 of a transcutaneous energy transfer
(TET) system. Sound processor 126 processes the output of
microphone 124 and generates encoded stimulation data signals which
are provided to external coil 130.
[0031] Internal components 144 comprise an internal receiver unit
132 including a coil 136 of the TET system, a stimulator unit 120,
and an elongate stimulating lead assembly 118. Internal receiver
unit 132 and stimulator unit 120 are hermetically sealed within a
biocompatible housing commonly referred to as a stimulator/receiver
unit. Internal coil 136 of receiver unit 132 receives power and
stimulation data from external coil 130. Stimulating lead assembly
118 has a proximal end connected to stimulator unit 120, and
extends through mastoid bone 119. Lead assembly 118 has a distal
region, referred to as electrode assembly 145, a portion of which
is implanted in cochlea 140.
[0032] Electrode assembly 145 can be inserted into cochlea 140 via
a cochleostomy 122, or through round window 121, oval window 112,
promontory 123, or an opening in an apical turn 147 of cochlea 140.
Integrated in electrode assembly 145 is an array 146 of
longitudinally-aligned and distally extending electrode contacts
148 for stimulating the cochlea by delivering electrical, optical,
or some other form of energy. Stimulator unit 120 generates
stimulation signals each of which is delivered by a specific
electrode contact 148 to cochlea 140, thereby stimulating auditory
nerve 114.
[0033] Electrode assembly 145 may be inserted into cochlea 140 with
the use of an insertion guide. It is noted that while the
embodiments detailed herein are described in terms of utilizing an
insertion guide or other type of tool to guide the array into the
cochlea, in some alternate insertion embodiments, a tool is not
utilized. Instead, the surgeon utilizes his or her fingertips or
the like to insert the electrode array into the cochlea. That said,
in some embodiments, alternate types of tools can be utilized other
than and/or in addition to insertion guides. By way of example only
and not by way of limitation, surgical tweezers like can be
utilized. Any device, system, and/or method of inserting the
electrode array into the cochlea can be utilized according to at
least some exemplary embodiments.
[0034] An atraumatic electrode array insertion process and
obtaining the correct final position of the electrodes has
utilitarian value with respect to obtaining utilitarian electrode
array insertion outcomes. In addition to trauma resulting from the
electrode impacting sensitive cochlea structure during insertion of
the electrode array, an anomalous final position of one or more
electrodes can impact the ultimate performance of the electrode
array. Such anomalous final positions can be, by way of example
only and not by way of example, the electrode array dislocating
from the scala tympani to the scala vestibuli. Another anomalous
position can be, for example, a scenario where the electrode is
inserted to an inappropriate depth. This can cause a frequency gap
and/or can cause some part of a pre-curved array to "bow" away from
the modiolus, resulting in greater current spread (sometimes
excessive current spread), relative to that which would be the case
without the bowing, etc. Also, the electrode tip could get stuck
during the insertion process, causing the electrode fold over
itself, which could cause excessive spread (or at least more
current spread relative to that been the case without the fold
over), and/or can require some electrodes to be disabled.
[0035] The teachings detailed herein are directed towards
identifying at least one of the aforementioned electrode array
insertion scenarios. Some embodiments can include utilizing
verifying electrode position via medical imaging (e.g., CT scan,
X-ray, etc.), which require the patient to be exposed to radiation
during the process of obtaining medical images, as well as the need
for medical equipment in the operating room to provide and
otherwise obtain the imaging, as well as a subsequent analysis by
an expert to assess the correct insertion of the electrode holder.
Some embodiments of the teachings detailed herein utilize such,
while other embodiments specifically do not utilize such, but
instead utilize other methods to evaluate or otherwise obtain
information indicative of a given electrode array insertion
scenario. Some embodiments include the action of measuring neuronal
activation after stimulation. This exemplary embodiment can require
subjective expert analysis and/or can also be dependent on having a
good/acceptable neural response. However, in some instances, such
is not always obtainable. Again, as with the aforementioned
imaging, some embodiments herein utilize such while other
embodiments specifically do not utilize such methods. In at least
some exemplary embodiments, methods of determining an insertion
scenario can utilize voltage measurements in the cochlea. In an
exemplary embodiment of such embodiments, the interpretation of the
obtained voltage measurements still requires subjective analysis by
an expert. In addition, these measurements can be rendered more
difficult to interpret than otherwise might be the case by the
presence of so-called air bubbles, open electrodes, shorted
electrodes, and/or electrode extrusion. Some embodiments of the
teachings detailed herein utilize the aforementioned voltage
measurements coupled with expert analysis, while in other
embodiments some of the teachings detailed herein specifically
avoid utilization of expert analysis to obtain or otherwise analyze
and electrode array insertion scenario.
[0036] Some embodiments include obtaining voltage measurements from
inside and/or outside the cochlea and analyzing them in, by way of
example only and not by way of limitation, an automated manner, by
comparing the voltage measurements to statistical data. Such can
enable the removal or otherwise the elimination of the use of
expert analysis to evaluate a given electrode array fold over based
on one of the obtained voltage measurements. Some such embodiments
enable the interpretation of the voltage measurements in a manner
that is robust to the variations in the cochlea environment that
may lead to incorrect results, including so-called false positives.
Robust results can have utilitarian value in at least some
exemplary scenarios because some of the anomalous positions only
occur very rarely (e.g., 1 in 70, 1 in 100, 1 in 150, etc.).
Accordingly, even a relatively small occurrence of false positive
identification of an anomalous position could far exceed the
natural occurrence of the anomaly and thereby render the
elimination of the expert analysis lacking utilitarian value.
[0037] FIG. 2A presents a side view of an embodiment of an
insertion guide for implanting an elongate electrode assembly
generally represented by electrode assembly 145 into a mammalian
cochlea, represented by cochlea 140. The illustrative insertion
guide, referred to herein as insertion guide 200, includes an
elongate insertion guide tube 210 configured to be inserted into
cochlea 140 and having a distal end 212 from which an electrode
assembly is deployed. Insertion guide tube 210 has a
radially-extending stop 204 that may be utilized to determine or
otherwise control the depth to which insertion guide tube 210 is
inserted into cochlea 140.
[0038] Insertion guide tube 210 is mounted on a distal region of an
elongate staging section 208 on which the electrode assembly is
positioned prior to implantation. A robotic arm adapter 202 is
mounted to a proximal end of staging section 208 to facilitate
attachment of the guide to a robot, which adapter includes through
holes 203 through which bolts can be passed so as to bolt the guide
200 to a robotic arm, as will be detailed below. During use,
electrode assembly 145 is advanced from staging section 208 to
insertion guide tube 210 via ramp 206. After insertion guide tube
210 is inserted to the appropriate depth in cochlea 140, electrode
assembly 145 is advanced through the guide tube to exit distal end
212 as described further below.
[0039] FIG. 2B depicts an alternate embodiment of the insertion
guide 200, that includes a handle 202 that is ergonomically
designed to be held by a surgeon. This in lieu of the robotic arm
adapter 202.
[0040] FIGS. 3A and 3B are side and perspective views,
respectively, of representative electrode assembly 145. As noted,
electrode assembly 145 comprises an electrode array 146 of
electrode contacts 148. Electrode assembly 145 is configured to
place electrode contacts 148 in close proximity to the ganglion
cells in the modiolus. Such an electrode assembly, commonly
referred to as a perimodiolar electrode assembly, is manufactured
in a curved configuration as depicted in FIGS. 3A and 3B. When free
of the restraint of a stylet or insertion guide tube, electrode
assembly 145 takes on a curved configuration due to it being
manufactured with a bias to curve, so that it is able to conform to
the curved interior of cochlea 140. As shown in FIG. 3B, when not
in cochlea 140, electrode assembly 145 generally resides in a plane
350 as it returns to its curved configuration. That said, it is
noted that embodiments of the insertion guides detailed herein
and/or variations thereof can be applicable to a so-called straight
electrode array, which electrode array does not curl after being
free of a stylet or insertion guide tube, etc., but instead remains
straight.
[0041] FIGS. 4A-4E are a series of side-views showing consecutive
exemplary events that occur in an exemplary implantation of
electrode assembly 145 into cochlea 140. Initially, electrode
assembly 145 and insertion guide tube 310 are assembled. For
example, electrode assembly 145 is inserted (slidingly or
otherwise) into a lumen of insertion guide tube 300. The combined
arrangement is then inserted to a predetermined depth into cochlea
140, as illustrated in FIG. 4A. Typically, such an introduction to
cochlea 140 is achieved via cochleostomy 122 (FIG. 1) or through
round window 121 or oval window 112. In the exemplary implantation
shown in FIG. 4A, the combined arrangement of electrode assembly
145 and insertion guide tube 300 is inserted to approximately the
first turn of cochlea 140.
[0042] As shown in FIG. 4A, the combined arrangement of insertion
guide tube 300 and electrode assembly 145 is substantially
straight. This is due in part to the rigidity of insertion guide
tube 300 relative to the bias force applied to the interior wall of
the guide tube by pre-curved electrode assembly 145. This prevents
insertion guide tube 300 from bending or curving in response to
forces applied by electrode assembly 145, thus enabling the
electrode assembly to be held straight, as will be detailed
below.
[0043] As noted, electrode assembly 145 is biased to curl and will
do so in the absence of forces applied thereto to maintain the
straightness. That is, electrode assembly 145 has a memory that
causes it to adopt a curved configuration in the absence of
external forces. As a result, when electrode assembly 145 is
retained in a straight orientation in guide tube 300, the guide
tube prevents the electrode assembly from returning to its
pre-curved configuration. This induces stress in electrode assembly
145. Pre-curved electrode assembly 145 will tend to twist in
insertion guide tube 300 to reduce the induced stress. In the
embodiment configured to be implanted in scala tympani of the
cochlea, electrode assembly 145 is pre-curved to have a radius of
curvature that approximates the curvature of medial side of the
scala tympani of the cochlea. Such embodiments of the electrode
assembly are referred to as a perimodiolar electrode assembly, and
this position within cochlea 140 is commonly referred to as the
perimodiolar position. In some embodiments, placing electrode
contacts in the perimodiolar position provides utility with respect
to the specificity of electrical stimulation, and can reduce the
requisite current levels thereby reducing power consumption.
[0044] As shown in FIGS. 4B-4D, electrode assembly 145 may be
continually advanced through insertion guide tube 300 while the
insertion sheath is maintained in a substantially stationary
position. This causes the distal end of electrode assembly 145 to
extend from the distal end of insertion guide tube 300. As it does
so, the illustrative embodiment of electrode assembly 145 bends or
curves to attain a perimodiolar position, as shown in FIGS. 4B-4D,
owing to its bias (memory) to curve. Once electrode assembly 145 is
located at the desired depth in the scala tympani, insertion guide
tube 300 is removed from cochlea 140 while electrode assembly 145
is maintained in a stationary position. This is illustrated in FIG.
4E.
[0045] Conventional insertion guide tubes typically have a lumen
dimensioned to allow the entire tapered electrode assembly to
travel through the guide tube. Because the guide tube is able to
receive the relatively larger proximal region of the electrode
assembly, there will be a gap between the relatively smaller distal
region of the electrode assembly and the guide tube lumen wall.
Such a gap allows the distal region of the electrode assembly to
curve slightly until the assembly can no longer curve due to the
lumen wall.
[0046] Returning to FIGS. 3A-3B, perimodiolar electrode assembly
145 is pre-curved in a direction that results in electrode contacts
148 being located on the interior of the curved assembly, as this
causes the electrode contacts to face the modiolus when the
electrode assembly is implanted in or adjacent to cochlea 140.
Insertion guide tube 500 retains electrode assembly 145 in a
substantially straight configuration, thereby preventing the
assembly from taking on the configuration shown in FIG. 3B.
[0047] The inability of electrode assembly 145 to curve to
accommodate the bias force induces stress in the assembly.
Pre-curved electrode assembly 145 will tend to twist while exiting
insertion guide tube 510 to reduce this stress. With the distal end
of the electrode assembly is curved to abut the lumen wall, the
assembly twists proximally.
[0048] This is illustrated in FIGS. 5A-5I. FIG. 5A is a side view
of perimodiolar electrode assembly 145 partially extended out of a
conventional insertion guide tube 500, showing how the assembly may
twist while in the guide tube. FIGS. 5B-5F are cross-sectional
views taken through respective sections 5B-5B, 5C-5C, 5D-5D, 5E-5E,
and 5F-5F of electrode assembly 145 in FIG. 5A.
[0049] As shown in FIGS. 5A-5F, the portion of electrode assembly
145 in insertion guide tube 510 is twisted about its longitudinal
axis, resulting in electrode contacts 148 in the twisted region to
have a different radial position relative to insertion guide tube
510. As shown in FIGS. 5A and 5G-I, as electrode assembly 145
exists in insertion guide tube 500, the assembly is free to curve
in accordance with its bias force. However, the orientation of
electrode contacts in the deployed region of the assembly is
adversely affected by the twisted region of the assembly remaining
in guide tube 510.
[0050] Accordingly, some embodiments detailed herein and/or
variations thereof are directed towards an insertion guide having
an insertion guide tube that maintains a perimodiolar or other
pre-curved electrode assembly in a substantially straight
configuration while preventing the electrode assembly from twisting
in response to stresses induced by the bias force which urges the
assembly to return to its pre-curved configuration. This generally
ensures that when the electrode assembly is deployed from the
distal end of the insertion guide tube, the electrode assembly and
insertion guide tube have a known relative orientation.
[0051] FIGS. 6A-6D are different views of but some exemplary
embodiments of insertion guide tube 210, referred to herein at
insertion guide tube 610. For ease of description, features of the
guide tube will be described with reference to the orientation of
the guide tube illustrated in the figures. FIG. 6A is a partial
cross-sectional view of an embodiment of insertion guide tube 210,
referred to herein as insertion guide tube 610. As can be seen,
insertion guide tube 610 includes an anti-twist section 620 formed
at the distal end of the guide tube. Anti-twist section 320 is
contiguous with the remaining part of guide tube 610. Guide tube
610 has a lumen 640 which, in proximal section 624 has a vertical
dimension 626, and an distal anti-twist section 620 has a smaller
vertical dimension 634 described below. The vertical dimension of
lumen 640 decreases from dimension 626 to dimension 634 due to a
ramp 648 at the proximal end of anti-twist section 642.
[0052] Anti-twist section 620 causes a twisted electrode assembly
traveling through guide tube 610 to return to its un-twisted state,
and retains the electrode assembly in a straight configuration such
that the orientation of the electrode assembly relative to the
insertion guide tube 610 does not change.
[0053] As shown in FIG. 6C, electrode assembly 145 has a
rectangular cross-sectional shape, with the surface formed in part
by the surface of the electrode contact, referred to herein as top
surface 650, and the opposing surface, referred to herein as bottom
surface 652, are substantially planar. These substantially planar
surfaces are utilized in embodiments of the insertion guide tube
described herein.
[0054] Tube wall 658 in anti-twist section 620 has surfaces 644 and
646 which extend radially inward to form an anti-twist guide
channel 680. Specifically, a superior flat 644 provides a
substantially planar lumen surface along the length of section 620.
As shown best in FIGS. 6A, 6B, and 6D, superior flat 644 has a
surface that is substantially planar and which therefore conforms
with the substantially planar top surface 650 of electrode assembly
145. Similarly, inferior flat 646 has a surface that is
substantially planar which conforms with the substantially planar
bottom surface 652 of electrode assembly 145. As shown in FIG. 6D,
when a distal region of electrode assembly 145 is located in
anti-twist section 620, the surfaces of superior flat 644 and
inferior flat 646 are in physical contact with top surface 650 and
bottom surface 652, respectively, of the electrode assembly. This
prevents the electrode assembly from curving, as described
above.
[0055] In an exemplary embodiment, during insertion and/or after
full insertion of the electrode array into the cochlea, stimulation
of at least 1 electrode pair of the cochlear implant is executed
and measurement/s are obtained that are related to the electric
field in the cochlea resulting from the aforementioned stimulation.
These measurements can be obtained by any utilitarian manner that
can provide data to enable the teachings detailed herein. The
stimulation intensity can be manually or automatically adjusted to
obtain a good resolution signal. One method for performing the
adjustment quickly and automatically is to measure the potential of
the electrodes closest to the stimulating pair and adjusting the
signal intensity and gain to ensure that this signal is using the
full dynamic range. Another method is to measure the electrodes
furthest from the stimulating pair with the narrowest separation
and adjusting the signal intensity and gain to ensure sufficient
level above the noise floor. In some exemplary embodiments, the
stimulation intensity is set at two current levels. In some other
embodiments, the stimulation intensity is set at other current
level values. In an exemplary embodiment, a stimulation intensity
is utilized that is the same throughout all the measurements.
Still, in at least some exemplary embodiments, the teachings
detailed herein can be executed along with a method action of
calibrating the stimulation intensity with respect to executing the
teachings detailed herein with respect to a given recipient. In
some embodiments, there is thus a control unit configured to
calibrate a stimulation intensity of the implantable system and
cause the implantable system to stimulate tissue based on the
calibration intensity so as to generate electrical current to
create the electrical phenomenon. In some embodiments, the control
unit is configured to execute the calibration procedure
automatically.
[0056] In some exemplary embodiments, the electrode potential
decays with distance in the case of fixed reference electrodes
(although, in some embodiments, not with respect to depth
sounding/modiolous wall distance, as well as impedance
spectroscopy--more on this below), and, in some exemplary electrode
array insertion scenarios, this decay pattern (or continuity
pattern in some other embodiments--a continuity pattern can have a
decay and then an increase, depending on what read electrodes are
being used relative to the stimulating electrodes--herein, decay
refers to the general phenomenon that voltage should decrease the
further one is away from the stimulating electrodes) is interrupted
by the presence of open electrodes, electrodes not in contact with
tissue and/or shunted electrodes. In some instances, the potentials
of the read electrodes change smoothly (e.g., depth sounding and/or
impedance spectroscopy), this smooth change pattern is interrupted
by the presence of open electrodes, electrodes not in contact with
tissue and/or shunted electrodes. Some things look like
discontinuity in a smooth change scenario. For example, a change in
direction could indicate fold over, a step change can indicate
scala dislocation. In some embodiments, the potentials change
smoothly and the attributes of the change/features of the change
can have utility with respect to identifying the given insertion
scenario. The teachings detailed herein can be implemented to avoid
confusing discontinuities/changes that can be utilitarian with
respect to determining a deleterious array insertion scenario with
those caused by open/short/shunt/bubbles, etc. Other scenarios that
can interrupt the decay pattern and/or continuity pattern exist.
There is utilitarian value in identifying the occurrence of the
phenomenon that interrupts the continuity pattern, or at least
identifying that a phenomenon exists that interrupts the
decay/continuity pattern (i.e., in some embodiments, it is not
necessary to identify specific phenomenon that interrupts the
decay/continuity pattern, but only to identify that a phenomenon
has occurred which will interrupt the decay pattern). This is
because, in some embodiments of the teachings detailed herein, the
decay pattern is utilized to determine whether or not one or more
anomalous events have occurred (sometimes referred to herein
deleterious events), such as by way of example only and not by way
of limitation, fold over (including tip fold over), bowing of the
electrode array, and dislocation (e.g., the puncturing of a wall of
the cochlea, such that one or more electrodes of the electrode
array have been driven outside the cochlea duct during the
insertion process). According to some embodiments, there are
devices, systems, and/or methods of combining several algorithmic
components such that the end result is the provision of a robust
determination of anomalous electrode position.
[0057] In an exemplary embodiment, there exists a method, as well
as a device and/or system, for the detection of electrodes that
should not be used in determining whether or not an anomalous
condition exists. Additional details of this will be described
below. For the moment however, it is noted that in at least some
embodiments, these electrodes may not be used because, by way of
example only and not by way of limitation, of an issue with the
electrode, current source or sensing circuit and/or because of the
presence of an air bubble proximate the electrode and/or because
the electrode is outside cochlea. In an exemplary embodiment,
method actions include the marking or removal of such electrodes so
that subsequent actions can avoid erroneous results/results that
might skew the data to result in a false positive resulting from
reliance on data obtained from these electrodes. In at least some
exemplary embodiments, the measurement results can be conditioned,
as will be described in greater detail below. Briefly, however, the
conditioning which can address variance due to noise,
manufacturing, contaminants, insertion artefacts etc., can be
executed to include one or more of the following: reduce the noise
of these measurements, improve the detection of defective
electrodes and scaling and normalised measurements at the interval
[0,1] prior to the process stage.
[0058] To put the aforementioned method action into context, FIG. 7
provides an exemplary algorithm for a method, method 797, that
includes method action 798, which includes obtaining data relating
to the utility of using data from one or more electrodes in the
recipient. Such method actions can correspond to any method action
that can result in the identification of one or more of the
phenomenon detailed above and/or as will be detailed below. Method
797 further includes method action 799, which includes identifying
the presence or absence of an anomalous occurrence while taking
into account the obtained data obtained in method action 799. In
this regard, method action 799 can include, following the
preliminary action of method action 798, one or more of actions
that result in one or more of the following determinations: [0059]
The determination of electrodes that are not in the cochlea and/or
the depth of insertion; [0060] The determination of electrodes that
are folded over (excluding those outside the cochlea); [0061] The
determination of electrodes that are bowing away from the modiolus
(excluding those outside the cochlea or faulty); [0062] The
determination of electrodes that are in the scala tympani
(excluding those outside the cochlea); [0063] The determination of
scala dislocation (where the array rides up and punctures the
basilar membrane and extends into the scala vestibule).
[0064] In at least some exemplary embodiments, the combination of
various of the above elements can allow for the elimination of
common sources of error in the algorithms aimed at identifying one
or more of the aforementioned individual issues that can occur
vis-a-vis the anomalous insertion. The individual determination
algorithms can also be applied in different orders to eliminate
bias. By way of example only and not by way of limitation, in an
exemplary embodiment, if a fold over is present, this may affect
the reliability of the algorithm to detect scala dislocation or
detecting electrodes bowing away from the modiolus. In some
embodiments, when the teachings detailed herein are used, at least
in combination with a measurement technique that includes
incremental updates, the determination of how many electrodes are
inside the cochlea and, in some instances, along with one or more
of the other determinations detailed herein, such can have
utilitarian value with respect to reducing and/or eliminating false
positives relative to that which would be the case in the absence
of such. In at least some exemplary embodiments, the exact
combinations are dependent on the individual algorithms. In at
least some exemplary embodiments, there can be utilitarian value
with respect to implementing the teachings detailed herein
utilizing a hierarchical determination. Also, some exemplary
embodiments include the combination of one or more algorithms,
where the combination is not executed in a strictly ordered
fashion, but instead, in an exemplary embodiment, the algorithm
could be combined in parallel and recurrent fashions.
[0065] That is, method 797, as noted above, includes method action
799, which includes identifying the presence or absence of an
anomalous occurrence while taking into account the obtained data
obtained in method action 798. In an exemplary embodiment, taking
into account the obtained data obtained in method action 798
includes conditioning the overall data. In this regard, in an
exemplary embodiment, there includes a method action corresponding
to conditioning the data, as distinct or otherwise distinguished
from a method action of normalizing the data (more on this below).
In an exemplary embodiment, the data is conditioned prior to
actions of processing, which actions of processing are utilized to
identify the presence or absence of an occurrence of an anomalous
condition.
[0066] Some embodiments included executing one or more of several
possible optional conditioning actions by observing that the
recorded data has some common aspects the removal of which and/or
the modification of which will result in improved reliability of
detection and/or the reduced likelihood of a false positive.
[0067] Some such data that has utilitarian value vis-a-vis
removal/modification thereof will now be described, along with some
exemplary embodiments of identifying such.
[0068] Embodiments can include several alternative methods for
determining electrode faults and/or determining specific anomalous
positions. In at least some exemplary embodiments, some of the
methods detailed herein are based on the representation of the
measurements on n electrodes as an n.times.n matrix, where the data
in each row correspond to the n observation made while stimulating
on a given electrode pair. However, in some alternate embodiments,
the representation could be changed, providing that such can enable
the teachings detailed herein.
[0069] With reference back to FIG. 7, again, there is utilitarian
value with respect to obtaining data relating to the utility of
using data from the electrodes in a recipient. In general, the
teachings detailed herein are directed to obtaining data in some
form or another from one or more electrodes that are implanted in a
recipient. (It is noted that the phrase "implanted in a recipient"
as used herein includes both properly implanted electrodes as well
as improperly implanted electrodes (e.g., electrodes that have been
driven through the basilar membrane from the scala tympani to the
scala vestibuli, such as through dislocation) as well as electrodes
that have not reached their ultimate implantation location, but
are, for all intents and purposes, are implanted in the recipient
(e.g., the most proximal electrode on the electrode array where
only the three or four most distal electrodes have been inserted
into the cochlea at a given temporal location.) This data can be a
result of the action of energizing an electrode of an electrode
array that is inside the cochlea, energizing an electrode of the
electrode array that is outside the cochlea, energizing an
electrode of the cochlear implant that is not part of the array,
etc. This can be a result of the action of using electrode/s of the
electrode array that is partially or fully inside the cochlea as a
read electrode/s (sometimes also referred to as observation
electrode/s--any electrode/s from which data is obtained that can
enable the teachings herein can be a read electrode/observation
electrode, relative to a reference), using an electrode of the
electrode array that is outside the cochlea as a read electrode,
utilizing an extra cochlear electrode as the read electrode, etc.
Note also that in at least some exemplary embodiments, there are
teachings directed herein to obtaining data from one or more
electrodes that are not part of the device that is implanted, or
otherwise not part of the device that will be implanted (e.g., the
cochlear implant), but is/are part of a device that is utilized
during the insertion process, providing that such can result in
obtaining data relating to the utility of utilizing data from one
or more electrodes in the recipient. Not only can this be the case
for a read electrode/s (or a plurality of such), such can also be
the case with respect to the energized electrode. That is, in an
exemplary embodiment, the source of the electrical field that is
sensed inside the cochlea can be generated or otherwise originated
at a location outside the cochlea, and the generator of the current
can be a device that is not part of the cochlear implant, but is a
separate device that is utilized during insertion. Additional
details of such will be provided below.
[0070] It is briefly noted that reference will often be made to
electrodes in the singular, such as the stimulation electrode or
the read electrode. It is to be understood that any such disclosure
is also made with the understanding that any read electrode
requires a reference, and thus typically another electrode, and any
energizing electrode needs a corresponding electrode to serve as
the sink, and visa/versa.
[0071] Still with reference to FIG. 7, and in particular, method
action 799, the action of identifying the presence or absence of
anomalous occurrence can be executed by analyzing a data matrix,
which is briefly referred to above, in some of the more specific
details of which will be provided below. This fact is briefly
mentioned here because the following will reference in some
instances, the matrix. For ease of understanding of the teachings
detailed herein, the more specific features of the matrix are
presented below, and thus the matrix will be referred to in the
general sense in the near-term.
[0072] Some exemplary embodiments of method action 798 include
determining electrode faults by, for example, in addition to the
usage of separate 2-point impedance measurements to detect open
circuits and/or short circuits, and/or making determinations
directly from the rows of the matrix (final, after full insertion,
and/or during "construction" of the matrix, as the rows are
established, for example) by observing that when an electrode is in
an open circuit state, it is disconnected from the current source,
so the electrode will not be able to emit the impulse, as the
connection has been interrupted. Some exemplary embodiments can
utilize this fact to make the potential received in other
electrodes null (0 and also negative values due to ADC) when the
affected electrode emits the impulse, and maximum when measured on
the electrode. FIG. 8 presents an exemplary conceptual example of
an electrode experiencing a short, and FIG. 9 presents an exemplary
voltage measurement resulting therefrom. FIG. 10 presents a
simplified matrix that could result where the third electrode of a
4 electrode array (or where only 4 electrodes of a 22 electrode
array have been measured) is experiencing an open circuit
condition. An Open-Circuit electrode can have a maximum potential
value of itself and close to .+-.zero (positive and negative
values) on the other electrodes (possibly due to errors in the AD
converter). As can be seen, the data in FIG. 10 shows an expected
decay/continuity with respect to electrodes 1, 2, and 4 (each row
represents the numeric electrode, with the diagonal showing the
energizement of that electrode). As can be seen, the blocks
associated with electrode 3 have a difference of about an order of
magnitude relative to the data associated with the other
electrodes.
[0073] FIG. 11 presents a three-dimensional plot of data points
associated with measurements from an electrode array. Electrode 22
is shown with an open circuit fault. One identifier of an open
circuit, or otherwise an indication thereof, is an abnormally high
value for the faulty electrode on the main diagonal i==j. Another
identifier of an open circuit, or otherwise an indication thereof,
is the presence of zero, or near zero, values for the faulty
electrode off the main diagonal [i,22], and [22,j] (i=j-[1,22]).
Accordingly, in an exemplary embodiment, a plot is presented to a
surgeon or the like or other healthcare professional according to
that seen in FIG. 11, or even the data seen in FIG. 10, the surgeon
can determine that an open circuit is likely to exist. Note also
that some embodiments include an automatic determination of such
utilizing a computer or the like based on an analysis of the
data.
[0074] In an exemplary embodiment, executing a direct detection can
save measurement time and/or can provide improved protection
against a single corrupt data point/bad data point. By direct
detection, it is meant that the data directly from a matrix is
used. An exemplary matrix with data representing an open circuit
fault is shown in FIG. 10. The rows/columns associated with the
faulty electrode are highlighted.
[0075] An exemplary embodiment of method action 798 includes
determining whether an electrode is outside the cochlea or not in
contact with tissue. In some exemplary embodiments, such can be
determined via the usage of separate 2 point measurements which
correlates a high impedance to a lack of tissue contact.
Alternatively and/or in addition to this, in an exemplary
embodiment, a determination can be made directly from the rows of
the matrix by observing that the potential on the electrode not in
contact with tissue will often or at least sometimes in a
statistically significant manner present a maximum value at the
stimulating electrode with a rapid drop and a low relatively
constant value on all other electrode. In at least some exemplary
embodiments, this value is higher than that which is observed in
the open circuit scenario.
[0076] FIG. 12 presents an exemplary conceptual example of an
electrode experiencing a non-insertion event, and FIG. 13 presents
an exemplary voltage measurement resulting therefrom. FIG. 14
presents a simplified matrix that could result where the fourth
electrode of a 4 electrode array (or where only four electrodes of
a 22 electrode array have been measured) is experiencing a
non-insertion/not yet inserted condition.
[0077] A no insert electrode can have a maximum potential value of
itself and low values on the other electrodes (as distinguished
from zero values, such as those of the open circuit). As can be
seen, the data in FIG. 14 shows an expected decay/continuity with
respect to electrodes 1, 2, and 3, and the blocks associated with
electrode 4 have a difference at least about an order of magnitude
relative to the data associated with the other electrodes.
[0078] FIG. 15 presents a three-dimensional plot of data points
associated with a matrix of no-insert electrodes, or otherwise an
indication thereof can be seen via the presence of the main
diagonal i==j, the presence of a high value on the specific
electrode, and the presence of low values on [i,1], and [1,j]
(i=j-[1,22]). Accordingly, in an exemplary embodiment, a plot is
presented to a surgeon or the like or other healthcare professional
according to that seen in FIG. 15, or even the data seen in FIG.
14, the surgeon can determine that a no insert condition is likely
to exist. Note also that some embodiments include an automatic
determination of such utilizing a computer or the like based on an
analysis of the data.
[0079] In an exemplary embodiment, executing direct detection can
save measurement time and/or can provide improved protection
against a single corrupt data point, relative to that which would
be the case without such direct detection. This method is also
applicable for the identification of electrodes affected by air
bubbles. (More on this below.)
[0080] For the determination of array fold over, there can be
utilitarian value with respect to representing such as a
cross-diagonal ridge if the measured values are visualized in
three-dimensional space with the Z-axis representing the size of
the observation, as seen in FIG. 36. It is noted that teachings
herein can be executed without utilizing such three-dimensional
spaces as well.
[0081] Points that might constitute such a ridge in some exemplary
embodiments, but not in others, can be obtained by identifying all
off-diagonal values deviating from a monotonic change or exceeding
a threshold. In some embodiments, this could be determined by
taking the difference between all successive points along vectors
parallel to the diagonal and comparing these to a pre-determined
value. In some other embodiments, this could be done by taking the
first derivative along the electrode rows moving away from the
stimulating electrode identifying all points where the derivative
changes sign. In yet another instance these points could have been
identified by the preceding conditioning step, which could be
executed using filtering, such as an edge filter, which can give
output points that can be used to determine a deviation from the
monotonic change.
[0082] In some embodiments, the confidence that a fold over is
present increases as more points are identified. It is further
observed that the confidence that a fold over is present increases
further if the points can be shown to lie in the axis orthogonal to
the diagonal. In one embodiment this can be identified by fitting a
polynomial to the identified points and determining whether the
slope lies orthogonal to the diagonal. In another embodiment this
can be identified by segmenting the observation matrix orthogonally
to the diagonal and observing the number of successive points
identified in each segment. In yet another embodiment the matrix
could be cross correlated with a set of ridge masking function and
the correlation thresholded. It is further observed that the
intersection of the ridge and the diagonal is the pivoting
electrode (the electrode where the electrode array bends). This
point could be identified in any of the above-mentioned ways.
[0083] Also, in some embodiments, it is the case that one or more
of the techniques detailed herein are not compatible with
incremental measurement methods, while others are. With respect to
the former, such is dependent on many measurements which may be
slow to obtain. For use with incremental measurement methods, there
can be the alternative method of utilizing stimulation of at least
one electrode pair and observation on at least two electrode pairs.
This embodiment is based on the observation that for wide
stimulation modes a monotonic change in voltage is expected as the
observation electrode moves away from the stimulation electrodes
and that a non-monotonic change (once confounding factors are
controlled for) represents a fold over. In one embodiment the
change could be detected by taking a derivative of the voltages and
determining if the direction of the slope changes by detecting a
change in the sign of the derivative. In another embodiment the
change could be detected by comparing each measurement to a more
apical measurement and detecting when the size of the measurement
increases.
[0084] To make the determination more robust in the presence of
movement--assuming the measurements are being conducted as the
array is inserted--the measurements could use filtering techniques
such as or similar to Kalman filters.
[0085] To increase the robustness of this method, it is observed
that the comparing the depth of the dip (the lowest point if there
has been a change in sign) with the average slope on the most basal
electrodes provides some robustness against variations in cochlea
anatomy. Comparing this relationship to a threshold provides
robustness against misinterpreting a noisy signal. These two
techniques taken together gives more robust detection.
[0086] An Alternative embodiment uses a narrow stimulation mode. In
this instance it is observed that the direction of current flow
will change if the electrodes involved in the narrow stimulation
mode changes order. This change in direction of the current will
lead to a change in voltage that can be detected by observing the
voltage close to the stimulation pair. In one instance this can be
done by stimulating on the most apical electrode pair and measuring
the voltage from the neighboring electrode pair. If the sign of the
voltage changes this indicates a possible fold over. As for the
wide mode the same filtering can be used to increase the robustness
of the determination in the presence of movement of the array.
[0087] As noted above, the teachings detailed herein can be
utilized to determine scenario of electrode bowing away from the
modiolus. In an exemplary embodiment, a slope of the voltage
decay/continuity is related to the conductive properties of the
elements in proximity of the stimulating and observation
electrodes, and this principle can be utilized to determine the
occurrence of such. In an exemplary embodiment, a distance
indication can be achieved by taking the derivative of the voltage
decay/continuity, the rate of voltage decay/continuity is somewhat
related to the distance between the electrode/s generating the
voltage and the bony cochlear wall. This is due to the effective
reactance changes as the amount of electric field passing through a
more conductive region is reduced. Alternatively, and/or in
addition to this, the distance can be determined utilizing the
measured voltages as parameters to a model that includes the
electrode distance. For example this model can be an algorithmic
model that predicts the effect of the distance between the
electrode and the cochlea wall on all the voltages measured with a
given measurement paradigm. The model can also be constrained by
knowledge about the electrode array design. For example the change
in distance cannot exceed the distance between two neighbouring
electrodes, while in other embodiments it can. In another example
this model can consist of pre-generated templates from a finite
element model, each template has a different predicted set of
voltage measurements and the set of measurements that most closely
match the measured voltages can be selected and thus the distances
determined from the best template.
[0088] In some scenarios, the degree of correlation with distance
of these approaches changes over time as scar tissue is formed.
Some exemplary embodiments compensate for this by using more than
one of these techniques to provide additional robustness, at least
if these measures are conducted some time after surgery, such as 2
days, 1 week, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks, 4, 5, 6, 7,
8, 9, 10, 11 or 12 months or more after surgery.
[0089] Additionally for the determination of electrodes that are
"bowing" away from the modiolus, in some embodiments, the presence
and state of cell matter surrounding an electrode can be detected
through Electrical Impedance Spectroscopy (EIS), while other
embodiments do not utilize such. Still, with respect to embodiments
that utilize such, in a scenario where a cochlear implant electrode
is surrounded by cell matter, it is likely to have a very different
EIS signature to an electrode surrounded by perilymph (which is
purely resistive). In some scenarios, this can be translated to
distance by conducting impedance spectroscopy measurements using
pairs of electrodes close together and using the ratio of
impedances in different spectral bands to determine how close the
electrode is to tissue. At least some embodiments rely upon the
fact that degree of correlation with distance of these approaches
changes over time as scar tissue is formed, and provide
compensation for such by using more than one of these techniques to
provide additional robustness if these measures are conducted some
time after surgery. It is also noted that in at least some
exemplary embodiments, any device, system, or method of determining
distance of an electrode of the electrode array from the modiolus
wall, such as via the utilization of depth sounding, can be
utilized in some embodiments.
[0090] Another exemplary aspect of an occurrence that can result in
data in the data matrix resulting in a false positive when analyzed
and/or obscuring the occurrence of an anomalous electrode position
can correspond to the feature of detrending. There tends to be a
baseline trend in the measurements reflecting a measurement offset
and the narrowing of the cochlear duct. This is seen by way of
example only and not by way of limitation in FIG. 16, which
provides an example of the baseline trend associated with the
narrowing of the cochlea.
[0091] In an exemplary embodiment, this trend can be removed by
subtracting the offset and rotating the matrix to minimize the
error in relation to a flat plane. Alternatively, a similarity
transformation can be used to normalize the matrix by observing
that the degree of similarity in the voltages recorded by electrode
i and j when all other electrodes are stimulating is closely
related to the electrical distance between those. This measure is
independent of the unknown peaks that can affect a distance matrix
and is symmetric
D(i,j)=norm(Z(idx,i)-Z(idx,j))/sqrt(length(idx)).
[0092] Another exemplary aspect of an occurrence that can result in
data in the data matrix resulting in a false positive when analyzed
and/or obscuring the occurrence of an anomalous electrode position
can correspond to the tendency of there to be variations, some
relatively small, in the measurements reflecting manufacturing
variation of the electrode surfaces and/or local anatomical
variation(s) in the area of the array. For detection of trends in
the array position, there is utilitarian value in removing these
variations (again, in a conditioning action). However, for
detection of a more localized global change (e.g., bowing of the
array) it is utilitarian to maintain these variations. In instances
where the removal is utilitarian, such can be achieved by one or
more filtering elements of the electrical potential measurements
where any of the implementations of these filters could be, median
filter; mean filter; adaptive filter; directional filtering; edge
enhancement filter (e.g., differentiation based filters like Sobel
filters or Canny edge detector).
[0093] In addition, or as an alternative to using a filter, and/or
in addition to, or as an alternative of removing a data point
entirely, an individual point in the matrix can be replaced by an
inferred point when the individual point may have been affected by
measurement error or noise. For example, in at least some exemplary
embodiments, the diagonal values in the matrix where at least one
of the stimulating and recording electrodes are shared can have an
open circuit, thus these measurements can be replaced by linear
interpolation of the neighboring elements. In some embodiments,
there are techniques related to maintaining a value over time such
that when there is a measurement error one can replace the bad
value/erroneous value with the one measured in the previous epoc.
Accordingly, the teachings detailed herein are directed towards
storing some or all data that is collected during the various data
collection actions/read/measurement actions, and retrieving such
data and utilizing such as a replacement or otherwise a stand-in
for data that is bad. Such an exemplary embodiment can entail
replacing a data point on the matrix with the stored data
previously obtained.
[0094] Another aspect that can be relied upon when developing
conditioning regimes and/or other data processing regimes having
utilitarian value is that that there tends to be variation in the
range between the minimum and maximum levels recorded in individual
cochlea, due to the differences in cochlea size, electrode array
configuration and biochemical differences. Some embodiments include
avoiding these variations by utilizing subsequent algorithms such
that the values can be adjusted within a set range, thus accounting
for these variations, and thus the regimes take into account such
variation.
[0095] FIG. 17 presents an exemplary algorithm for an exemplary
method, method 1700, which includes method action 1710, which
includes obtaining information indicative of a phenomenon sensed at
a read electrode of a cochlear implant electrode array (again,
relative to a reference) and/or at an electrode remote from the
electrode array due to one or more electrodes of the cochlear
implant electrode array being energized. With respect to the
former, this can correspond to obtaining information indicative of
a phenomenon sensed at electrode 2 due to electrode 1 being
energized and/or due to a remote electrode being energized, as long
as an electrode of the electrode array is utilized as the read
electrode, relative to a reference, this feature is met. With
respect to the latter, this can correspond to obtaining information
indicative of a phenomenon at a remote electrode, such as, for
example, an extra cochlea electrode (ECE) (such as the plate/can or
so-called hardball electrode) or an electrode that is utilized as
part of the method, such as an electrode that is part of or
otherwise supported by an electrode array insertion tool (more on
this below). As long as the phenomenon is a result of energizement
of one or more of the electrodes of the electrode array, this
feature is met.
[0096] Method 1700 further includes method action 1720, which
includes executing a first analysis of the information obtained in
method action 1710 to identify one or more first meanings from
among a first group of meanings of the sensed phenomenon. In an
exemplary embodiment, the first group of meanings includes or
otherwise is a result of at least one of an open circuit, a short
circuit, a shunt circuit, a bubble proximate the electrode array,
an electrode not in the cochlea, an electrode conditioning
phenomenon (as opposed to the conditioning process detailed
herein), or a detrending phenomenon.
[0097] Briefly, it is noted that method action 1720 does not
require that the specific type of phenomenon has occurred. Instead,
it is sufficient to identify that a phenomenon based on one or more
of the aforementioned examples has occurred. Indeed, in an
exemplary embodiment, the shunt circuit could potentially yield
similar results to the presence of a bubble, and/or the presence of
a bubble could yield similar results to an open circuit. Still, in
some embodiments, the identification of one or more first meanings
can correspond to identifying the actual underlying phenomenon.
Still further, the action of identifying the one or more first
meanings can include identifying the specific phenomenon, such as a
short circuit, as well as identifying another phenomenon in more
general terms/only that the phenomenon exists.
[0098] The open circuit and the electrode not in the cochlea and
the detrending phenomenon have been described above. With respect
to the short circuit, this can correspond to a value at the read
electrode or whatever electrode is being utilized that is
abnormally high relative to that which would otherwise be the case.
By way of example only and not by way of limitation, if the voltage
reading on an electrode is the same as or relatively close to the
voltage reading at another electrode, such can be indicative of a
short between the two electrodes. Still further by way of example
only and not by way of limitation, if the voltage reading on
electrode three is the same as or relatively close to the voltage
applied to electrode two or otherwise the voltage read at electrode
two, such can be indicative of a short between those two
electrodes. Any device, system, and/or method that will enable a
determination that there exists a short circuit can be utilized in
at least some exemplary embodiments. Note also that this is the
case with respect to determining that there exists an open circuit
and/or an electrode not in the cochlea and/or the detrending
phenomenon. Indeed, in an exemplary embodiment, this is the case
with respect to any of the features detailed herein associated with
the first meanings.
[0099] With respect to a shunt circuit, in an exemplary embodiment,
perilymph or another conductive fluid or semi conductive fluid or
the like can creep into the electrode array or otherwise establish
a conductive bridge between one electrode and another electrode.
The phenomenon will not be the same as a short electrode, at least
in some embodiments, but will still potentially skew the data of
the matrix that is utilized to ultimately identify the anomalous
electrode position. In an exemplary embodiment, the data set can be
analyzed. In an exemplary embodiment, the voltage readings will be
higher than that which would be the case with respect to an open
circuit, but lower than that which would be the case with respect
to a short circuit, at least in some embodiments. For example, a
shunt can be indicated, at least in a matrix measurement, by a
secondary peak, which can look similar to that which would exist
for a fold over, but unlike a fold over this would only be present
in a single row. In an exemplary embodiment, empirical data is
obtained to develop a statistically significant database, and
comparisons of the data obtained from method action 1710 to this
statistically significant database can be executed to identify the
occurrence of the shunt circuit, or at least that there exists one
or more first meanings.
[0100] With respect to a bubble proximate the electrode array, in
an exemplary embodiment, an air bubble can be present proximate a
read electrode and/or a stimulating electrode, which bubble can
skew or otherwise create data that is less than utilitarian with
respect to the matrix. In at least some exemplary embodiments, such
bubbles can dissipate with time, especially if the electrode array
is further inserted into the cochlea, or otherwise can move to
other electrodes. Some additional ramifications of this will be
described in greater detail below, along with treating the data
accordingly.
[0101] With respect to an electrode conditioning phenomenon (as
distinguished from data conditioning), in at least some exemplary
embodiments, one or more electrodes of the electrode array will
experience a phenomenon akin to a corrosion scenario when the
electrode is exposed to body fluids. A chemical reaction takes
place on the surface of the electrode. Over time, this can change
the ultimate result of the data that is obtained for use in
determining whether or not an anomalous electrode position has
occurred. By way of example only and not by way of limitation, in
an exemplary embodiment, the data resulting from utilizing
electrode 2 as a read electrode just after electrode 2 is inserted
into the cochlea could be different than that which would result
from utilizing electrode 2 is a read electrode after electrodes 3,
4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18, for
example, are also inserted into the cochlea (i.e., electrode 2 is
subjected to more time being exposed to the perilymph/body fluids
relative to its first use as a read electrode) owing to the effects
of the electrode conditioning. Alternatively, and/or in addition to
this, conditioning can occur as a result of the electrode being
utilized as a stimulating electrode and/or because it is subject to
electrical current. Regardless of how the electrode conditioning
occurs, in an exemplary embodiment, method action 1720 includes
executing a first analysis to identify one or more first meanings
that can be a result of electrode conditioning.
[0102] Method 1700 further includes method action 1730, which
includes conditioning the obtained information based on the
identified one or more first meanings. Some details of the action
of conditioning will be described in greater detail below. Briefly,
however, in an exemplary embodiment, such as with respect to the
data set of FIG. 10, interpolation can be executed to replace the
3,3 location with a value of 2 (as that is what should be the case
with respect to the other electrodes), and to replace the 3,1
location with a value of 0.065 (halfway between 0.09 and 0.04),
replace the 3,2 location with a value of 0.1 (as that is what read
electrode 2 reads when electrode 1 is energized, and that is about
what read electrode 1 reads when electrode 2 is energized), and the
3,4 location with a value of 0.1 (for the same reasons relating to
the replacement of the 3,2 location). Still further, the 1,3
location (that reads -0.001) can be replaced with a value of
0.0.75, as that is halfway between 0.1 and 0.04, the 2,3 location
can be replaced with a value of 0.1, as that is the value of the
1,2 location, or can be replaced with a value that is interpolated
between 2 and 0.05, or a combination thereof, and the 4,3 location
can be replaced with 0.09, as that is the value of the 2,1
location, or can be replaced with a value that is halfway between 2
and 0.051, or combination thereof.
[0103] Alternatively, and/or in addition to this, method action
1730 can include establishing a matrix that ignores or otherwise
discounts the 1,3, 2,3, 3,3, 3,4, 3,1, 3,2, and 3,4 locations, or
otherwise flags those data points as being data that should be
ignored in the ultimate evaluation. Indeed, the action of
conditioning the obtained information can simply correspond to
flagging the information as being problematic or otherwise is being
information that should be discounted in some manner.
[0104] Speaking of the ultimate evaluation, method 1700 includes
method action 1740, which includes executing a second analysis of
the conditioned information to identify one or more second meanings
from among the second group of meanings of the sensed phenomenon.
Some additional details of such will be described in greater detail
below. Briefly however, in an exemplary embodiment, such
corresponds to analyzing a conditioned data matrix and comparing
the data to statistically significant results in deducing that an
anomalous electrode position exists. More details of this will be
described below. However, it is briefly noted that in some
exemplary embodiments, method action 1740 is not executed until
after the prior methods of method 1700 are executed multiple times.
In this regard, it is to be understood that in at least some
exemplary embodiments, method actions 1710, 1720, 1730 are executed
a plurality of times, such as for example only and not by way of
limitations, a number of times corresponding to the number of
electrode arrays that have been inserted into the cochlea by the
time that method action 1740 is executed.
[0105] In an exemplary embodiment, method action 1710 is executed
each time an electrode of the electrode array is inserted into the
cochlea. It is noted that in an exemplary embodiment, the
measurements are repeated continuously and the post processing
determines when another electrode has been inserted/correlates the
data temporally and/or position ally (where position is relative to
location on the array). Further, By way of example only and not by
way of limitation, in an exemplary embodiment, method action 1710
and, in some embodiments, method action 1720 and/or method action
1730 is executed after electrode 1 (the most distal electrode of
the electrode array) is inserted into the cochlea, and then method
action 1710 is again executed after electrode 2 (the second most
distal electrode of the electrode array) is inserted into the
cochlea, and so on until all 22 electrodes are inserted into the
cochlea. That said, in an exemplary embodiment, method action 1710
is executed each time only after a plurality of electrodes are
inserted into the cochlea relative to that which was previously
inserted into the cochlea where method action 1710 was executed
last time. For example, method action 1710 is executed after the
first three electrodes are inserted into the cochlea, and then
after the next three electrodes are inserted into the cochlea and
so on. Also, in an exemplary embodiment, method action 1710 is
executed after the first three electrodes are inserted into the
cochlea, and then each time after an electrode is inserted into the
cochlea. Any regime that links the electrodes inserted into the
cochlea to the method actions detailed herein can be utilized in at
least some exemplary embodiments.
[0106] In an exemplary embodiment of method 1700, the one or more
second meanings relates to a feature that impacts the condition of
electricity globally relative to the electrode array. By way of
example only and not by way of limitation, such can correspond to
that which results from fold over, electrode array bowing and/or in
electrode array located outside the cochlea or otherwise dislocated
with the specific duct of the cochlea. By way of example only and
not by way of limitation, these are phenomena that cannot be
detected if the location of the source and/or the sink utilized to
execute method 1710 were not known. In this regard, in an exemplary
embodiment, such is the case because the data associated there with
his relative to the position of other electrodes. This can be
distinguished from, for example, the phenomenon which corresponds
to the aforementioned first meanings, where the location of at
least one of the source or the sink need not be known for the
phenomenon to be identified, or at least to determine that
something indicative of such phenomenon exists. In this regard, in
an exemplary embodiment, the one or more first meanings relates to
a feature that is identifiable irrespective of which of a plurality
of potential intracochlear sources of current corresponding to
respective electrodes of the cochlear array supplies current to the
read electrode. Again, this can be distinguished from, for example,
the aforementioned phenomenon associated with the anomalous
positioning of the electrode array at least in some exemplary
embodiments, and thus in some exemplary embodiments, the one or
more second meanings relates to a feature that is identifiable only
if a specific electrode is known of a plurality of potential
intracochlear sources of current corresponding to respective
electrodes of the cochlear array supplies current to the read
electrode.
[0107] In some embodiments, the one or more first meanings
corresponds to an electrical phenomenon that at least one of will
not change (e.g., open or short circuit) or will change with time
without further movement of the electrode array in the cochlea
(e.g., shunt circuit, bubble, electrode conditioning), all other
things being equal. Conversely, the one or more second meanings
can, in some embodiments, correspond to electrical phenomenon that
will only change with further movement of the electrode array in
the cochlea, all other things being equal (fold over, bowing,
dislocation).
[0108] Accordingly, in an exemplary embodiment, the first group of
meanings includes at least one of an open circuit, a short circuit,
shunt circuit, a bubble proximate the electrode array, an electrode
not in the cochlea, an electrode conditioning phenomenon, or a
detrending phenomenon, and the second group of meanings includes at
least one of fold over, tip puncture, bowing, or electrode array
misplacement.
[0109] It is noted that any disclosure herein of fold over
corresponds to a disclosure of tip fold over as well as fold over
of the main body of the electrode. In this regard, tip fold over is
a specific type of fold over that occurs rather wise is generally
limited to the tip of the electrode array. Some additional features
of this scenario are described below with respect to the fact that
in some exemplary scenarios, tip fold over may not necessarily
result in a scenario where the electrode array is repositioned,
whereas fold over at another location of the electrode array may
result in such. It is noted that any disclosure herein of tip fold
over also corresponds to a disclosure of the main body fold over
and vice versa.
[0110] By electrode array misplacement, it is meant that the
electrode array is located in a cavity in the body not intended. In
this regard, by way of example only and not by way of limitation,
in at least some exemplary embodiments, the electrode array is
intended to be placed into the scala timpani. If the electrode
array instead winds up in the scala vestibuli, such would result in
electrode array misplacement. Still further, if the electrode array
instead winds up in the scala media, such would result in electrode
array misplacement. Also, it is noted that in an exemplary
embodiment, during insertion, the tip of the electrode array could
potentially pierce the inner boundary of the scala timpani, such
that when the electrode array is fully inserted, or even partially
inserted, the distal portions of the electrode array are no longer
in the scala timpani, but instead in, for example, the scala
vestibuli and/or the scala media. Such corresponds to a dislocation
phenomenon. Accordingly, in an exemplary embodiment, with respect
to method 1700, the first group of meanings includes least one of
an open circuit, a short circuit, a shunt circuit, a bubble
proximate the electrode array, an electrode not in the cochlea, an
electrode conditioning phenomenon or a detrending phenomenon, and
the second group of meanings includes electrode array
dislocation.
[0111] Some exemplary scenarios of method action 1710 are executed
as a result of data obtained during the actual electrode array
insertion process, that is, while the electrode array is being
inserted into the cochlea. Thus, in an exemplary embodiment, the
phenomenon sensed at the read was sensed while the electrode array
was being inserted into the cochlea. Conversely, some exemplary
scenarios of method action 1710 are executed after the electrode
array has been fully inserted into the cochlea (whether or not that
full insertion has properly placed the cochlea--by full insertion,
it is meant that the surgeon believes that he or she can no longer
further insert the electrode array into the cochlea or otherwise
should not further insert the electrode array into the cochlea
because doing so would reduce the effectiveness of the cochlear
implant these of the channel alignment with the tonotopical
features of the cochlea). It is also noted that at least some
exemplary embodiments of the execution of method action 1710 can be
executed prior to the action of inserting the electrode array into
the cochlea. By way of example only and not by way of limitation,
in at least some exemplary embodiments, an open and/or short
circuit determination can be made prior to removing the electrode
array from shipping packages. In an exemplary embodiment, this data
is provided to a control unit that assists or otherwise controls or
otherwise execute one or more or all of the method actions detailed
herein, as will be described in greater detail below.
[0112] With reference to method 1700, it is noted that in at least
some exemplary embodiments, the phenomenon associated with method
action 1710 corresponds to an interruption of the continuous
pattern of a column or row of the matrix or of the data points in
general. For example, if the most distal electrode of the electrode
array fully inserted into the cochlea is stimulated with reference
to an extra-cochlear electrode, the voltage readings at the other
electrodes with reference to an extra-cochlear electrode should
decay with distance from the most distal electrode, until, at
least, approaching another stimulating electrode (hence why
sometimes continuity is referred to.) If one or more of the
electrodes indicates a voltage reading that is not decaying or
otherwise decays in a manner that is different than the general
trend, this can be indicative of one or more of the meanings of
method action 1720. In this regard, in an exemplary embodiment, the
first analysis can entail determining whether or not there exists
an abnormality in a continuous pattern of the obtained information,
such as an abnormality in the voltages read at the read electrodes.
In an exemplary embodiment, the column and/or row and/or the entire
matrix can be compared against a statistically significant and/or a
theoretical template (it is noted that any disclosure herein of a
statistically significant data set also corresponds to an
embodiment that utilizes a theoretical data set and vice versa). If
the data is similar to the statistically significant and/or
theoretical template, a determination can be made that the
information is not indicative of one or more of the first meanings.
That said, in an exemplary embodiment, the statistically
significant and/or theoretical template can be based on one that
which corresponds to the existence of the one or more meetings.
Thus, if the data is similar to the statistically significant
and/or theoretical template, a determination can be made that the
information is indicative of one or more the first meanings.
[0113] Briefly, in an exemplary embodiment of the interruption of a
continuous pattern, an open circuit for example would interrupt the
continuous pattern. Alternatively, and/or in addition to this,
electrodes that are not in contact with tissue and/or electrodes
that are not in the cochlea can also interrupt the continuous
pattern. Accordingly, a continuous pattern with an interruption can
be utilized in a first analysis of the information to identify one
or more the first meanings.
[0114] It is noted that some utilitarian features of the teachings
detailed herein can result in relatively fast identification of the
one or more second meanings. In this regard, in an exemplary
embodiment, an identification can be made in a relatively short
timeframe that a fold over and/or a bowing and/or a dislocation has
occurred, tip puncture, etc., while the recipient is still in
surgery, and, in some embodiments, while the surgeon is still
holding the electrode array during insertion process. In some
embodiments, the second group of meanings is identified at least
one of before or no later than X minutes after full insertion of
the electrode array into the cochlea, where X is 0.1, 0.2, 0.3,
0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6,
7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20. Additional
features as well as some of the exemplary utilitarian value of this
embodiment will be described in greater detail below.
[0115] Briefly jumping ahead, FIG. 31 provides another exemplary
flowchart according to an exemplary method, the parallels to this
and method 1700 can be seen, while tailored to the specific
phenomenon associated with an open circuit and a no insert
electrode. Some additional details of this are described below.
Briefly, FIG. 31 is a subroutine to be executed in the automatic
methods detailed herein, just as method 1700 can be executed in the
automatic methods detailed herein.
[0116] FIG. 18 presents an exemplary flowchart for an exemplary
method, method 1800, which includes method action 1810, which
includes commencing insertion of a cochlear electrode array into a
cochlea of a person. In an exemplary embodiment, this can be done
by hand while in other exemplary embodiments, this can be done by
tool, such as a robotic insertion tool some of the details of which
will be described in greater detail below. Method 1800 further
includes method action 1820, which includes energizing a
stimulation electrode of the electrode array that is located inside
the cochlea or an electrode remote from the electrode array. By way
of example only and not by way of limitation, in an exemplary
embodiment, the cochlear implant assembly that includes the
receiver stimulator in the electrode array assembly can be
activated so as to provide an electrical signal to one or more of
the electrodes of the electrode array. In an exemplary embodiment,
this can be executed by providing an inductance signal to the
receiver of the receiver stimulator, which inductance signal was
received activates the electrode array. Any device, system, and/or
method that can enable the energization of a stimulation electrode
can be utilized in at least some exemplary embodiments.
Alternatively, and/or in addition to this, in an exemplary
embodiment, the so-called hardball or ECE can be used.
Alternatively, and/or in addition to this, a separate electrode
that is separate from the implant can be used, such as an electrode
that is mounted on an insertion tool, the details of which will be
described in greater detail below.
[0117] Method action 1830 of method 1800 includes the action of
reading a read electrode that received an electrical signal from
the energized stimulation electrode. In at least some exemplary
embodiments, this can correspond to utilizing one or more of the
electrodes of the electrode array as a read electrode.
Alternatively, and/or in addition to this, in an exemplary
embodiment, the so-called hardball or ECE can be used.
Alternatively, and/or in addition to this, a separate read
electrode that is separate from the implant can be used, such as an
electrode that is mounted on an insertion tool, the details of
which will be described in greater detail below. While method
action 1830 requires that the read electrode be part of the
electrode array of the energized stimulation electrode is an
electrode remote from the electrode array, this does not mean that
if the energized stimulation electrode of method action 1820 was an
electrode of the electrode array, the read electrode of method
action 1830 must be an electrode that is separate from the
electrode array. In this regard, method actions 1820 and 1830 can
both be executed utilizing electrodes of the electrode array.
[0118] Method 1800 further includes method action 1840, which
includes determining, based on the reading, that a physical
characteristic associated with the electrode array that is strictly
local to the electrode array existed and/or exists. By "strictly
local" to the electrode array, it is meant that the phenomenon
exists regardless of where one of the source or sink electrode
would be located. For example, an open circuit, a short circuit, or
a shunt circuit can be determined utilizing any of the sources or
sinks, providing at least that the location of one is known. Still
further by example, the presence of a bubble can be determined, or
at least the effects associated there with, providing that one of
the locations of the source or sink is known. This is also the case
with electrode conditioning, detrending, and outside electrode.
Conversely, fold over determination for example, requires the
location of both the source in the sink to be known.
[0119] In at least some exemplary embodiments of method 1800, the
physical characteristic is a temporally static characteristic
related to a physical condition of the electrode array. That is, a
condition that does not change with time.
[0120] Conversely, in an exemplary embodiment, the physical
characteristic is a temporally dynamic characteristic related to
the physical condition of the electrode array. By way of example
only and not by way of limitation, in an exemplary embodiment, the
electrode conditioning is a physical characteristic that will
change with time. Also by way of example, the shunt condition is a
condition that will change with time. Conversely to these physical
characteristics that are temporally dynamic, in some embodiments,
the physical characteristic is a temporally dynamic characteristic
that is related to the location of the electrode array. By way of
example only and not by way of limitation, the presence of a
bubble, electrode non-insertion, and the detrending characteristics
are all characteristics that will vary based on the location of the
electrode array.
[0121] In an exemplary embodiment of method 1800, there exists the
action of reading other read electrodes that received the
electrical signal from the energized stimulation electrode. In an
exemplary embodiment, this can be executed in the same manner as
method action 1830, at least with respect to embodiments where the
read electrode is a read electrode of the electrode array. Still
further, in an exemplary embodiment of method 1800, there is the
additional action of identifying a continuous electrical phenomenon
associated with the electrodes that were read. By way of example
only and not by way of limitation, in a scenario where the
energized electrode was the most apical electrode/the most distal
electrode, a pattern should be seen where the voltage read at each
of the electrodes decreases with respect to distance from that
apical electrode. In an exemplary embodiment of method 1800, the
action of determining of method action 1840 is based on a
determination that the reading of method action 1830 is an abnormal
reading relative to the identified decaying/continuity electrical
phenomenon.
[0122] That said, in some exemplary embodiments, it is not
necessary to obtain information from other read electrodes. In this
regard, as noted above, in some exemplary embodiments, the obtained
readings can be compared to statistically significant data and/or
theoretical data, and a determination can be made based on the
comparison. Accordingly, in an exemplary embodiment of method 1800,
there is the additional action of obtaining information relating to
an electrical phenomenon continuity pattern of the electrode array
(e.g., such as obtaining a statistically significant and/or
theoretical based template), wherein the action of determining is
based on a determination that the reading is an abnormal reading
relative to the obtained electrical phenomenon continuity
pattern.
[0123] As noted above, embodiments of the teachings detailed herein
can be utilized to condition the data that is ultimately used to
make a determination of an anomalous electrode insertion. While
some embodiments of this conditioning results in the permanent
discounting of data from one or more of the read electrodes and/or
data associated with one or more stimulating electrodes, in some
other embodiments, the conditioning results in only temporarily
discounting of the data. For example, in a scenario where, for
example, data is obtained where a short circuit exists and/or a
bubble is proximate an electrode, which results in the data being
skewed, embodiments include obtaining further data at a later
temporal period, such as when the electrode array is moved further
into the cochlea, where the phenomenon that caused the data to be
skewed is no longer present. This new data is utilized in the
matrix and the old data can be eliminated. Accordingly, in an
exemplary embodiment, as seen in FIG. 19, there is method 1900.
Method 1900 includes executing method action 1910, which includes
executing method 1800. Method 1900 also includes method action 1920
which includes, after the determining action of method action 1840,
adjusting a location of the electrode array in the cochlea and
executing a second reading of the read electrode or of another read
electrode of the electrode array. By way of example only and not by
way of limitation, in an exemplary embodiment, the action of
adjusting the location of the electrode array in the cochlea can
push the electrode array further into the cochlea. Again, in an
exemplary embodiment, method 1800 can be executed with the
electrode array only partially inserted into the cochlea.
[0124] Method 1900 further includes method action 1920, which
includes determining, based on the reading, that the physical
characteristic associated with the electrode array determined in
method action 1840 has changed. Such can have utilitarian value
with respect to determining that the phenomenon that skewed or
otherwise interfered with the data that would ultimately be
utilized to determine the anomalous electrode position is now
producing a different result (if it is still present, that is).
[0125] FIG. 20 presents an exemplary flowchart for an exemplary
method, method 2000 which includes method action 2010, which
includes executing method 1800, and method action 2020, which
includes executing method action 1920. Method 2000 also includes
method action 2030, which includes determining, based on the second
reading, that the physical characteristic associated with the
electrode array no longer exists. Such can have utilitarian value
with respect to determining that the phenomenon that skewed or
otherwise interfered with the data that would ultimately be
utilized to determine the anomalous electrode position is no longer
present, and thus the specific data can be so utilized or otherwise
can be utilized in its raw form (albeit for potential
normalization).
[0126] FIG. 21 presents an exemplary flowchart for an exemplary
method, method 2100, which includes method action 2110, which
includes executing method 1800. Method 2100 also includes method
action 2120, which includes the action of adjusting a location of
the electrode array, whether such is repositioning the electrode
array or simply further inserting the electrode array, and
executing a second reading of the read electrode or of another read
electrode of the electrode array. Method 2100 also includes method
action 2130, which includes determining, based on the second
reading, that the physical characteristic is a first characteristic
as opposed to a second characteristic because the second reading,
after the movement, is effectively different than the reading of
method 1800. By way of example only and not by way of limitation,
in an exemplary embodiment, the first characteristic can correspond
to the existence of a shunt circuit, a bubble, a detrending feature
and/or electrode conditioning, and the second characteristic can
correspond to an open circuit or a short circuit.
[0127] FIG. 22 presents an exemplary flowchart for an exemplary
method, method 2200, which includes method action 2210, which
includes executing method 1800, and method action 2220, which
includes executing method action 2120. Method 2200 also includes
method action 2230, which includes determining, based on the second
reading, that the physical characteristic is a second
characteristic as opposed to a first characteristic because the
second reading, after the movement, is effectively the same as the
reading.
[0128] It is noted that in at least some exemplary embodiments,
method 1800 and/or the methods associated therewith detailed above
is/are executed prior to the execution of any method actions that
would lead to a determination that an anomalous electrode location
exists. In an exemplary embodiment, method 1800 and the methods
associated there with are executed a plurality of times prior to
the execution of any method actions that would lead to a
determination that an anomalous location exists. By way of example
only and not by way of limitation, method 1800 can be executed each
time an electrode is inserted to the cochlea, where after a certain
number of electrodes are inserted into the cochlea (e.g., 2, 3, 4,
5, 6 electrodes, or more, etc.). Still, it is noted that a
continuous measurement regime can also be used. Also, there could
be switching to other measurements based on what is observed. For
example, one can establish a single row of matrix to detect when
another electrode is inserted, once a full measurement on all of
the electrodes in the cochlea is executed, and then one can return
to a given row and evaluate that row. That said, in an exemplary
embodiment, method 1800 (or method 1700, for that matter), is
executed only after the electrode array has been fully inserted
into the cochlea. Any regime that links the number of electrodes
inserted into the cochlea to method 1800 and the methods associated
there with can be utilized in at least some exemplary
embodiments.
[0129] FIG. 23 presents an exemplary flowchart for an exemplary
method, method 2300, which includes method action 2310, which
includes executing method 1800 N number of times, where N can be 1,
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,
21, 22, or more. In an exemplary embodiment, method 1800 is
executed in a manner that is related to the number of electrodes
that have been inserted into the cochlea, such as after all of the
electrodes have been inserted into the cochlea, including only
after all of the electrodes have been inserted into the cochlea.
Method action 2320 includes conditioning the obtained information
based on the reading(s) of method action 2310 that a physical
characteristic associated with the electrode array that is strictly
local to the electrode array existed and/or exists. It is noted
that while the embodiments of FIG. 23 depict method 2320 being
executed only after method 2310 is executed the number of times
represented by N, in an alternate embodiment, a method exists where
method action 2310 is executed M number of times, followed by the
execution of method action 2320, and then followed by the execution
of method action 2310 P number of times, followed by the execution
of method action 2320, and then followed by the execution of method
action 2310 Q number of times, followed by the execution of method
action 2320, and then followed by the execution of method action
2310 R number of times, followed by the execution of method action
2320, and then followed by the execution of method action 2310 S
number of times, followed by the execution of method action 2320,
and then followed by the execution of method action 2310 T number
of times, followed by the execution of method action 2320, and then
followed by the execution of method action 2310 U number of times,
followed by the execution of method action 2320, and then followed
by the execution of method action 2310 V number of times, followed
by the execution of method action 2320, and then followed by the
execution of method action 2310 W number of times, followed by the
execution of method action 2320, and then followed by the execution
of method action 2310 L number of times, followed by the execution
of method action 2320, and then followed by the execution of method
action 2310 J number of times, followed by the execution of method
action 2320, and so on, where M, P, Q, R, S, T, U and V and W and L
and J can be any number of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
12, 13, 14, 15, 16, 17, 18, 19, 20, 21, or 22 in some embodiments,
and M and P and Q and R and S and T and U and V and W and L and J
need not equal each other. Further, the above can be extrapolated
out for any number of executions of method action 2310 followed by
the execution of method action 2320. Thus, it can be seen that an
action of conditioning can be executed prior to the execution of
all of the method actions corresponding to method 2310.
[0130] FIG. 24 presents an exemplary flowchart for an exemplary
method, method 2400, which includes method action 2410, which
includes executing method 1800 N number of times, starting at N=1
and Y=1. It is noted that while the embodiment of FIG. 24 keys off
of method 1800, in an exemplary embodiment, not all of the method
actions of method 1800 are executed at method action 2410 in some
alternate embodiments. In this regard, any one or more or all of
the method actions of method 1800 are executed at method action
2410. Method 2400 also includes method action 2420, which includes
conditioning the obtained information based on the readings that a
physical characteristic associated with the electrode array that is
strictly local to the electrode array existed and/or exists. Method
2400 also includes method action 2430, which includes the action of
executing method 1800 D(Y) number of times, and adding D to N, and
adding 1 to Y, and continuing until N=XYZ, and if not, returning to
method action 2420. In this regard, in an exemplary embodiment,
D(Y) can be any integer (and for the purposes of this application,
zero is to be considered an integer, recognizing a school of
thought that zero is not an integer) between 0 and 22, 0 and 30, 0
and 40, 0 and 50, 0 and 100 or 0 and 1000 (inclusive), and Y can be
any integer between 0 and 22, 0 and 30, 0 and 40, 0 and 50, 0 and
100 or 0 and 1000 (inclusive), and N can be any integer between 1
and 22, 1 and 30, 1 and 40, 1 and 50, 1 and 100 or 1 and 1000
(inclusive). For example, for D(1), D could be 3, and for D(2)
(Y=2) D could be 4, etc. This goes on until N=ZYZ, which is a
predetermined value corresponding to any of the aforementioned
integers. In an example where N=22, such as for a 22 channel
cochlear electrode array, the loop of method 2400 would be executed
until N equals 22 (i.e., all the electrodes are in the cochlea).
That said, even for a 22 channel electrode array, N could equal 30
or 40 or more, depending on how many times one seeks to execute
method 1800 for a given insertion depth. Indeed, in an exemplary
embodiment, after all the electrodes are inserted, method 1800 can
be executed 4 or 5 times, just to "wait out" any physical
phenomenon that will temporally change, such as air bubbles or
shunt or electrode conditioning, and once a stable set of values
has been obtained, that will be the data set used.
[0131] As with method action 2410, not all of the method actions of
method 1800 are executed at method action 2430 in some alternate
embodiments. In this regard, any one or more or all of the method
actions of method 1800 are executed at method action 2430.
[0132] FIG. 25 represents an exemplary flowchart for an exemplary
method, method 2500, which method actions are indicated as being
similar to the method 2400 detailed above, except as indicated.
Here, method action 2530 was executed in a manner analogous to
method action 2430, except that after this method action is
executed, the method proceeds to method action 2540, which entails
executing method 2330, with the caveat that this is done until
N=ZYZ, and if not, the method returns to method action 2420.
[0133] It is noted that in an exemplary embodiment of methods 2400
and/or 2500, any disclosure with respect to one or more of the
method actions associated with method 1800 can correspond also to a
disclosure of executing one or more of the method actions of method
1900, method 2000, method 2100 and/or method 2200.
[0134] FIG. 26 presents an exemplary flowchart for an exemplary
method, method 2600, which includes method action 2610, which
includes executing method action 1710 N number of times, starting
at N=1 and Y=1. Method 2600 also includes method action 2620, which
includes executing method action 1720 and, optionally, method
action 1730. Method 2600 also includes method action 2630, which
includes, executing method action 1710 D(Y) number of times and add
D to N, and add 1 to Y, and continue until N=XYZ, and if not,
returning to method action 2420. Method 2600 also includes method
action 2640, which includes optionally executing method action
1730, such as if this was not executed in method action 2620 (but
it can be re-executed as well), and determining that an anomalous
electrode location exists based on the conditioned information
and/or executing method action 1740.
[0135] To reiterate, some of the method actions detailed herein can
be executed during insertion of the electrode array, and can be
executed continuously or otherwise in a stepwise fashion for
incremental insertions the electrode array, and in other
embodiments, the method actions detailed herein can be executed
after the electrode array is fully inserted into the recipient. It
is also noted that these actions can be executed both during the
insertion process and after the insertion process is completed. In
some embodiments, the teachings detailed herein can provide an
indication to the surgeon or the like of an anomalous electrode
location prior to full insertion of the electrode array. In an
exemplary embodiment, can be the case with respect to providing an
indication upon the insertion of but not more than 1, 2, 3, 4, 5,
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,
24, 25, 26, 27, 28, 29, or 30 electrodes of the electrode
array.
[0136] In view of the above, it can be seen that the various method
actions detailed herein are executed one or more times prior to
developing or finalizing the ultimate matrix that is utilized to
determine whether or not there exists an anomalous electrode
location. In some exemplary embodiments, such can enable redundancy
in the methods detailed herein. In an exemplary embodiment, it can
be seen that in some instances, there are physical phenomena that
exist during some temporal periods and/or locations of the
electrode array, such as insertion depth, and do not exist during
some other temporal periods and/or locations of the electrode
array. By repeating some of the method actions detailed herein, and
obtaining multiple data points for the same electrodes/same
locations along the array, redundancy can be provided. This is
because two or three or more data sets can be developed for the
same location along the electrode array and/or for the same
location of the electrode array in the cochlea, and data sets that
are erroneous can be discounted or otherwise replaced with data
sets that are not erroneous. In an exemplary embodiment, if a data
set indicates an anomalous voltage reading, and any subsequent data
set does not include that anomalous voltage reading, the subsequent
data set can be utilized. Corollary to this is that if the prior
data set contained readings that were not in error, but the later
data set did contain such readings, the prior data set can be
utilized. Note also that in an exemplary embodiment, the redundancy
can be applied to replace only some rows and/or some columns and/or
only some data points of the ultimate matrix that is utilized to
identify the anomalous electrode location, such those detailed
herein, for example (dislocation, fold over, etc.).
[0137] In some exemplary embodiments, redundancy can be achieved
via testing for an open circuit in two ways. First, if the given
electrode is energized, the readings from the other electrodes can
be utilized to analyze or otherwise determine whether that
energized electrode is in an open circuit. Second, if a given
electrode is utilized as a read electrode, and there are no
readings of that electrode, such can also be utilized to determine
that such is an open circuit. Still further, as noted above, in
some exemplary embodiments, air bubbles or the like can interfere
with readings. By utilizing other electrodes, redundancy features
can be implemented to avoid the deleterious effects of the air
bubble. Still further, because the teachings detailed herein can be
executed in a temporally progressing manner, the air bubble may be
moved or otherwise dissipate, thus providing additional redundancy
to the system. The devices, systems, and our methods detailed
herein can be directed toward such or otherwise configured to
embrace or otherwise take advantage of such redundancy. Also,
reverse redundancy can be used. For example, one can detect a
short, then the short resolves itself, and short re-appears. Based
on this, one can (the system/computer can) remove a given electrode
from further measurements because identified intermittent issue
that could confuse the data or otherwise unexpectedly result in
erroneous data.
[0138] To be clear, in an exemplary embodiment, the teachings
detailed herein can provide redundancy with respect to measuring
and/or testing for the same condition two or more different
ways.
[0139] Moreover, the redundancy can enable multiple
embodiments.
[0140] That said, in some exemplary embodiments, readings for other
portions of the matrix can be utilized to fill-in or otherwise
replace erroneous readings. By way of example only and not by way
of limitation, in an exemplary embodiment, such as where 19 of 22
electrodes are inserted into the cochlea, and the first electrode,
the most distal electrode, is stimulated, and a reading at
electrode 18 is clearly anomalous, the reading from electrode 17
can be utilized for the reading at electrode 18. Also, one could
avoid stimulating electrode 18 and instead could do more frequent
stimulation or reading on electrode 17, or any other utilitarian
electrode, to replace what would otherwise be the stimulation or
reading on that electrode.
[0141] In some exemplary embodiments, there are methods according
to the teachings detailed herein which implement only selective
conditioning of the data. In an exemplary embodiment, as
demonstrated above, there is utilitarian value with respect to
conditioning the data prior to normalizing and/or prior to
utilizing the data to determine the existence of an anomalous
electrode location. That said, in another exemplary embodiment,
there is utilitarian value with respect to specifically not
conditioning the data prior to normalizing and/or prior to
utilizing the data to determine the existence of an anomalous
electrode location. That is, non-conditioned data is utilized to
determine the existence of an anomalous electrode location. (It is
noted that all disclosures herein with respect to the determination
of the existence of an anomalous electrode location also
corresponds to a disclosure of determining that an anomalous
electrode location does not exist.) That said, in another exemplary
embodiment, there is utilitarian value with respect to utilizing
data that is conditioned in a different manner from other data that
is utilized to determine the existence of an anomalous electrode
location. That is, differently conditioned data is utilized to
determine the existence of one or more types of anomalous electrode
locations as opposed to conditioned data that is used to determine
the existence of one or more other types of anomalous electrode
locations. For example, for the anomalous electrode location
relating to fold over, conditioned data that has been conditioned
to account for detrending is utilized, whereas for the anomalous
electrode location relating to electrode bowing, the data is
conditioned, but not conditioned to account for the detrending
phenomenon. That is, in an exemplary embodiment, two separate data
sets are utilized to determine the existence of these two separate
anomalous electrode location scenarios.
[0142] Further, while some embodiments include executing a
normalization process on the conditioned data, some embodiments
specifically exclude executing a normalization process on the
conditioned data. Thus, in some exemplary embodiments, two separate
data sets are utilized to determine the existence of separate
anomalous electrode location scenarios. For example, normalization
is executed with respect to determining the presence or absence of
fold over, but not to determine the presence or absence of
buckling, but one may do so for bucking in some embodiments. In
some embodiments, there will instead be no detrending for
buckling.
[0143] It is noted that while the embodiments herein often present
normalizing as a later action/an action executed just before
performing method action 1740, or even an action that is part of
method action 1740, in other embodiments, the normalizing can be
executed before the conditioning action, such as immediately after
obtaining measurements from the read electrodes.
[0144] In view of the above, with respect to method 1700, in an
exemplary embodiment, there is the additional action of executing a
second conditioning action on the obtained information based on the
identified one or more first meanings. There is also the additional
action of executing a third analysis of the second conditioned
information to identify one or more third meanings from among a
second group of meanings of the sensed phenomenon.
[0145] Accordingly, in an exemplary embodiment, the methods
detailed herein can include the action of selectively conditioning
the data/conditioning the data in different manners based on the
type of electrode location anomaly that is sought to be identified
(which includes seeking to identify the absence of such).
[0146] FIG. 27 presents an exemplary flowchart for another
exemplary method, method 2700. Method 2700 includes method action
2710, which includes obtaining information indicative of a
phenomenon sensed at a read electrode of a cochlear implant
electrode array. Method 2700 also includes method action 2720,
which includes using that information to determine whether or not a
deleterious cochlear electrode array position exists inside the
cochlea of a recipient. Such action can be executed according to
any of the teachings detailed herein and/or variations thereof. In
an exemplary embodiment of method 2700, the actions used to make
the determination correspond to a statistically based accuracy
rating of at least GG out of 100 vis-a-vis a determination that a
deleterious position exists (not just whether or not it exists, but
of the times that such deleterious position is indicated, it is
accurate) where GG is 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90,
91, 92, 93, 94, 95, 96, 97, 98, 99, 99.9, 99.99, 99.999, 99.9999,
99.999999 or 100. (In some embodiments, GG is any value between 97
and 100, inclusive, in 0.0000001 increments.) In this regard, in an
exemplary embodiment, method action 2720, when executed utilizing
certain actions, results in a correct determination of whether or
not the deleterious cochlear electrode array position exists,
vis-a-vis a determination that a deleterious position exists (not
just whether or not it exists, but of the times that such
deleterious position is indicated, it is accurate) for example, 90
times out of 100 times, 95 times out of 100 times, all other things
being equal. That is, the teachings detailed herein enable method
action 2720 to be executed with a high confidence level relative to
other actions utilized to make such a determination according to
method action 2720. In an exemplary embodiment, this can be because
the data is conditioned according to the teachings detailed herein
prior to making the determination.
[0147] It is noted that in an exemplary embodiment, the actions
used to make the determination that a deleterious position exists
(not just whether or not it exists, but of the times that such
deleterious position is indicated, it is accurate) executed in
method 2720 correspond to a statistically based accuracy rating of
at least GG out of 99, 98, 97, 96, 95, 94, 93, 92, 91, 90, 89, 88,
87, 86, 85, 84, 83, 82, 81, or 80, where, of course, GG is never
greater than one of those numbers.
[0148] In an exemplary embodiment, method action 2720 results in a
determination that a deleterious position exists. In an exemplary
embodiment, the likelihood that the determination is wrong upon
such determination is less than HH out of 100, where HH is 20, 19,
18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5,
0.1, 0.05, 0.01, 0.001, 0.0001, 0.00001 or 0. (In some embodiments,
HH is any value between 3 and 0, inclusive, in 0.0000001
increments.) In this regard, as noted above, there is negative
utilitarian value with respect to receiving false positives with
respect to determining whether or not, for example, one of the
anomalous electrode positions has occurred or otherwise exists. In
at least some exemplary prior art methods that attempt to determine
whether or not an anomalous electrode position exists, the number
of false positives can be high. Indeed, to the extent that many of
the prior art methods have deficiencies, it is that they provide an
indication that an anomalous electrode position exists when none
exists. By implementing at least some of the teachings detailed
herein, in an exemplary embodiment, the aforementioned reliability
can be obtained. In an exemplary embodiment, method action 2720
results in a determination the likelihood of which such is wrong is
less than HH out of 125, 150, 175, 200, 225, 250, 300, 350, 400,
450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, or 1000. In
an exemplary embodiment, the determination is a determination that
a fold over exists, and thus, the likelihood that the determination
is wrong can be less than, for example, 2 out of 100, 2 out of 175,
etc., in accordance with the above teachings. In an exemplary
embodiment, the determination is a determination that a fold over
does not exist, and thus the likelihood that the determination is
wrong can be less than, for example, 1 out of 500.
[0149] In an exemplary embodiment, the determination is a
determination that a dislocation has occurred, and thus the
likelihood that the determination is wrong can be less than, for
example, 5 out of 150, 2 out of 100, etc. In an exemplary
embodiment, the determination is a determination that bowing has
occurred, or any other occurrence of any other phenomenon. With
respect to fold over,
[0150] In view of the above, in an exemplary embodiment there is
the method 2700, further comprising, starting with N=2, an action
"iii" which includes obtaining Nth information indicative of an Nth
phenomenon sensed at an Nth read electrode of an Nth cochlear
implant electrode array. This exemplary method further includes an
action "iv," which includes using that Nth information to determine
whether or not a deleterious cochlear electrode array position
exists inside the cochlea of an Nth recipient. This method includes
repeating actions "iii" and "iv" a number of times, such as until
method 2700 is executed 100 times. When described in terms of an
algorithm, the method includes adding 1 to N, and repeating actions
"iii" and "iv" until N=100. It is noted however that any such claim
to such action is only for the purposes of accounting. It is not
necessary to actually add a number to N. In any event, in an
exemplary embodiment of this example, of the N determinations,
where N=100, at least GG of the determinations were accurate.
[0151] It is noted that the use of "first, second, third, etc."
herein is used in terms of providing a proper noun for a given
feature or action. Thus, with respect to the above, when N equals
100, the 100.sup.th electrode can be any electrode one and
electrode array having 22 electrodes.
[0152] Corollary to the above, in an exemplary embodiment, there is
the method 2700, further comprising, starting with N=2, an action
"iii" which includes obtaining Nth information indicative of an Nth
phenomenon sensed at an Nth read electrode of an Nth cochlear
implant electrode array. The method further includes an action
"iv," which includes utilizing that Nth information to determine
whether or not a deleterious cochlear electrode array position
exists inside the cochlea of an Nth recipient. Consistent with the
algorithm approach detailed above, the method also includes adding
1 to N, and repeating actions "iii" and "iv" until at least N=100,
wherein of the determinations that a deleterious position existed,
no more than 5% were false positives.
[0153] In accordance with the teachings detailed above, in an
exemplary embodiment, method action 2720 includes first
conditioning the information and then analyzing the conditioned
information to make the determination. In an exemplary embodiment
of such, method 2700 further comprises, after the conditioning
action of the information in prior to the analyzing of the
information, normalizing the conditioned information and then
analyzing the normalized conditioned information to make the
determination. That said, as noted above, some embodiments
purposely avoid normalization of the data. Accordingly, in an
exemplary embodiment, there is the action of reanalyzing the
information without normalizing or analyzing the information before
the normalizing to make a second determination as to whether or not
another type of deleterious cochlear electrode array position
exists inside the cochlea of the recipient, this "another type"
being different than that which was the subject of method action
2720. By way of example only and not by way of limitation, in an
exemplary embodiment, the first type can be fold over, and the
second type can be a bowing deleterious position. Note also that in
an exemplary embodiment, the action associated with first
conditioning the obtained information can correspond to first
conditioning the obtained information in a first manner and then
performing the analysis for the occurrence of bowing, and then
further conditioning the obtained information in a second manner
(e.g., including accounting for detrending, as opposed to the first
manner which did not so account for such), and then normalizing and
then performing a second analysis for the occurrence of fold over.
Note that in the aforementioned exemplary embodiment, instead of
further conditioning, the data can be completely reconditioned.
[0154] An exemplary embodiment of method 2700 further includes,
after method action 2710, the action of determining whether or not
to execute a conditioning action on the obtained information and/or
what type of conditioning action is to be executed on the obtained
information. Further, in this exemplary embodiment, after the
action of determining whether or not to execute the conditioning
action and/or after determining the type of conditioning action,
normalizing the information and analyzing the normalized
information to make the determination.
[0155] In an exemplary embodiment of method 2700, after action
2710, there is an action of executing a first type of conditioning
on the information. After executing the first type of conditioning,
method action 2720 is executed based on the conditioned information
conditioned according to the execution of the first type. In an
exemplary embodiment, there is also the action of executing a
second type of conditioning different from the first type of
conditioning; and the method includes analyzing the conditioned
information conditioned according to the execution of the second
type to determine whether or not a second type of deleterious
cochlear electrode array position exists inside the cochlea
different from that determined in method action 2720. In an
exemplary embodiment, the first type can include accounting for
detrending, and the second type can include not accounting for
detrending, or vice versa.
[0156] Still further, in an exemplary embodiment, there can be the
action of executing a normalizing action when the information is
conditioned according to the second type prior to analyzing such.
Alternatively, and/or in addition to this, there can be the action
of not executing a normalizing action one the information
conditioned according to the first type prior to analyzing
such.
[0157] In at least some exemplary embodiments, the result of the
action of determining whether or not to execute the conditioning
action is a determination not to execute the conditioning action,
and the action of normalizing the information can correspond to
normalizing the non-conditioned information. That said, in at least
some exemplary embodiments, the results of the action of
determining what type of conditioning action is a determination to
execute a type of conditioning action that is conducive to
determining whether or not fold over has occurred, and the action
of normalizing the information corresponds to normalizing the
conditioned information conditioned according to the type of
conditioning that is conducive to determining whether or not fold
over has occurred.
[0158] Conversely, the result of the action of determining what
type of conditioning action is a determination to execute a type of
conditioning action that is conducive to determining whether or not
dislocation has occurred and method 2700 also includes determining
not to normalize the information conditioned in accordance with the
type of conditioning action that is conducive to determining
whether or not dislocation has occurred.
[0159] In some embodiments, such as where the electrode array has
pierced the basilar membrane, the impedance jumps across the
membrane, or otherwise that there is an upward change or a
discontinuity across the membrane, or, a statistically unusual
degree of change between measurements crossing the membrane, and
the measurements from the read electrodes can be utilized to
identify the scenario. In at least some exemplary embodiments, the
read electrodes reveal a discontinuity in the measurements. In at
least some exemplary embodiments, a given type of discontinuity can
be correlated to a dislocation. Some discontinuities will be
different than others, and in some exemplary embodiments, at least
based on statistical and/or empirical data, a given discontinuity
scenario can be correlated to the statistical samples and such can
be utilized to determine the presence or absence of dislocation/to
distinguish a dislocation scenario from other readings indicative
of other phenomena.
[0160] In view of the above, it is to be understood that the
devices, systems, and/or methods detailed herein can have
utilitarian value with respect to helping to satisfy an expectation
during the surgery that implants a cochlear implant of correct
insertion of electrode array, at least after the surgical
procedure. Indeed, in an exemplary embodiment, the teachings
detailed herein can have utilitarian value with respect to
improving the general placement of the cochlear implant electrode
array vis-a-vis placement of the electrodes in a localized manner
in the scala tympani, such that the spiral ganglion cells are
directly stimulated and the current dispersion is reduced relative
to that which would be the case without the teachings detailed
herein. Such can have utilitarian value with respect to reducing
the amount of current consumption and improving the resolution of
the stimulation vis-a-vis the achieved location of the electrode
array relative to that which would be the case in the absence of
the teachings detailed herein. Such improvement can correspond to
an improvement of GG out of 100 relative to that which be the case
in the absence of utilizing the teachings detailed herein.
[0161] At least some teachings detailed herein can prevent or
otherwise limit the likelihood of an inadequate insertion
trajectory to the basal turn of the cochlea during the
cochleostomy, and thus reduce the likelihood that there can exist
damage the basilar membrane, osseous spiral lamina and lateral
cochlear walls and/or the likelihood that the electrode array could
be displaced from the scala tympani to the scala vestibuli across
the basilar membrane or osseous spiral lamina. At least some
embodiments of the teachings detailed herein utilize techniques to
determine the position of the electrode array within the cochlea
utilizing radiology imaging methods, like fluoroscopy,
phase-contrast radiography, rotational tomography (RT), combination
of conventional radiographs and computed tomographic (CT) images,
fusion of preoperative and postoperative CT imaging and micro-CT
scanning. That said, some exemplary methods and techniques going to
the teachings detailed herein explicitly do not utilize such
radiological imaging methods/none at all, at least within 30, 45,
60, 75, 90, or 120 minutes after the electrode array is fully
inserted into the cochlea. Accordingly, some exemplary embodiments
include executing one or more or all of the method actions detailed
herein without executing such radiological methods within the
aforementioned time periods. That said, one might exclude
radiological methods if a normal result is obtained/the data
indicates no anomalous electrode positioning, while using such
methods if an abnormal result is obtained so as to confirm the
results.
[0162] Such exclusion can include conventional cochlear view
(X-ray) or high resolution CT (HRCT) are also commonly used for
vestibular electrode insertion, scalar dislocations or tip folding
evaluation. Such exclusion can also include cone beam computed
tomography (CBCT).
[0163] Again, some exemplary methods detailed herein are executed
without the consultation or the evaluation of an expert to verify
the correct position of the electrodes. In an exemplary embodiment,
the evaluation is executed in an automated and/or semi-automated
manner. The end result can be provided to the surgeon or other
healthcare professional based entirely on computer
analysis/automated analysis. The end result of the analysis can be
provided in a detailed manner and/or or can be a binary good/bad
indication. This result can also be presented continuously as the
array is inserted using, visual, auditory or haptic feedback or a
combination of these.
[0164] Some embodiments can utilize Spread of Excitation (SOE) to
determine whether or not tip fold over has occurred, and which can
provide surgeons an intraoperatory tool that let them detect
positioning problems. However, some embodiments explicitly exclude
the utilization of such, while in other embodiments may utilize
such but exclude the utilization of such to base the final
diagnosis thereupon, whereas in some embodiments, methods 1700 to
2700 are so utilized to base the final diagnosis thereupon. One can
also use conditioning alongside a neural response, rate of decay,
and also when measuring stimulation artifacts. Some embodiments can
utilize neural responses in combination with the methods disclosed
above to provide further robustness or confirmation of the
electrode position and add information about the electrode position
in relation to the surviving neural body position.
[0165] In view of the above, an exemplary embodiment includes an
automated system that makes use of the implant electronics to give
feedback of the electrode array position before the patient leaves
the operation theatre. In addition, if a wrong insertion exists,
utilizing the teachings detailed herein, at least in some
embodiments, such wrong insertion can be detected and corrected,
avoiding unnecessary surgical re-intervention and radiation.
[0166] Some embodiments base the detection process on potential
decay in a medium:
V = k Q r Eq . 1 ##EQU00001##
where V is the electrical potential, k is the Coulomb's constant
(Nm.sup.2/C.sup.2), Q is the charge C and is the distance to the
charge. It can be deduced that the lower the distance the higher
the voltage received and vice versa.
[0167] An exemplary embodiment of the procedure is as follows.
First, an electrode is stimulated in accordance with any of the
teachings detailed above and/or any other manner that will enable
the teachings detailed herein, and the received electric potential
along the electrode array is recorded. In an exemplary embodiment,
the neighbor electrode is then selected and the next data set is
saved, repeating until the whole electrode array has been
stimulated. Moving away from the stimulating electrode, the
potential should decay in accordance with Eq. 1. In a perfect
insertion, or at least a normal insertion, a maximum value will be
seen on the stimulating electrode and a minimum value on the
farthest one. In Fold over case, the global maximum will be the
stimulating electrode but another local maximum will rise up,
indicating the fold over.
[0168] Utilizing the teachings herein, such can provide utilitarian
value of avoiding exposure of the recipient to radiation and the
saving of surgical time because a separate imaging process is not
needed.
[0169] Teachings detailed herein can enable the presence of tip
fold over without radiation, along with the
accuracies/reliabilities detailed above at least in some
embodiments, in the surgical theatre (as opposed to the
radiological theater) and such can be executed in some instances
automatically. The success rate will be evaluated with the
implemented automatic system, intraoperatively.
[0170] For the detection (which can correspond to, for example,
method action 1710 above), some embodiments of the system are based
on the measurement of the electric potential generated by the
activation of an electrode. The goal of at least some exemplary
embodiments is to provide to the surgeon a tool to validate the
correct insertion of the electrode array in a few seconds, if not a
few minutes, if not the times detailed above, after full insertion
(again, less than 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3,
3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 minutes from the
time of full insertion (the 22 second electrode or the last
electrode of the array being inserted into the cochlea). Consistent
with the teachings detailed herein, the system is designed, in some
embodiments to detect the presence of tip fold over, as well as
short-circuited and/or not inserted electrodes.
[0171] The applied signal to the electrodes can be a biphasic
square signal, which amplitude level is settled to 200 current
levels, corresponding to 648 .mu.Amps. The gain factor is fixed at
0.2 units. The potential measurements can be done in the moment
corresponding to the end of the first trailing edge.
[0172] The data can be recorded in a k.times.k matrix. The rows
define the target electrode, where the measurement is made at, and
the columns refer to the active electrode, where the stimulus is
produced. In some embodiments, the electrode arrays utilized are
the CI532 and CI512 from Cochlear Ltd..TM., and thus the total
among of electrodes is k=22. It is to be understood that in some
alternate embodiments, the teachings detailed herein can be
modified so as to account for electrode arrays having less than 22
electrodes or more than 22 electrodes, such as, for example,
electrode arrays that have 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30,
31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 50, 60, 70, 80, 90, 100,
150, 200, 250, 300, 350 or 400 or more electrodes or any value or
range of values inclusively therebetween in 1 increments (77, 222,
12 to 399, etc.). Still, with respect to a 22 electrode array, in
total 484 measurements are recorded in at least some exemplary
embodiments to generate the full matrix data.
M V = [ V 1 , 1 V 1 , 2 V 1 , s V 2 , 1 V 2 , 2 V m , 1 V m , s ]
.A-inverted. m , s = [ 1 : k ] Eq . 2 ##EQU00002##
where m is the measured electrode and s is the stimulated
electrode. In this embodiment, all the electrodes are sequentially
stimulated, and the received potential is recorded in all of the
electrodes, including in the stimulated electrode. FIG. 28 depicts
the obtained matrix that is exposed (a voltage matrix). When the
tip fold over appears, a matrix with a second diagonal besides the
principal diagonal can be observed, as seen in FIG. 28. The
intersection between the main diagonal and the second matrix
indicates the place where the fold over occurs, identifying the
pivoting electrode and providing information about how severe the
fold over is, as it has been test in previous laboratory tests. The
main diagonal is
Y=X Eq. 3
[0173] And the second diagonal, when the tip folds over case,
is
Y=aX+b Eq. 4
In at least some embodiments, the electric potential always decays
with distance (Eq. 1), so the relative position of the electrodes
can be correlated with the measured potential, in order to deduct
the relative position between them. In a tip fold over situation
(FIG. 30--where the graph depicts the voltage for the given measure
electrode), an increase of the received potential is detected,
compared with the normal situation (no tip fold over--FIG.
29--where the graph depicts the voltage for the given measure
electrode), in a place where the potential should be reducing
(FIGS. 29 and 30 depict measured potential with stimulation of the
most apical electrode).
[0174] Briefly, as noted above, in some exemplary scenarios, an
open electrode exists, and this skews the data. FIGS. 8 and 9 are
thus comparable to FIGS. 29 and 30 in the general sense. As noted
above, embodiments can take into account that an electrode is in
Open-Circuit it is disconnected from the current source, so the
electrode will not be able to emit the impulse, as the connection
have been interrupted. This fact will make the potential received
in other electrodes null (0 and also negative values due to ADC)
when the affected electrode emits the impulse, and maximum when
measured on that electrode, which phenomenon is depicted above in
FIGS. 8 and 9, vis-a-vis measured potential while stimulation in an
open circuit case.
[0175] Also, as noted above, sometimes, part of the electrode array
stays outside of the cochlea (lack of space, ossifications,
cochlear diameter, etc.). The electrodes affected have, in some
embodiments, a similar behavior as the Open Circuit ones. The
received potential is maximum when the measured electrode is the
stimulated one, however, neighbor electrodes have low potential
values, but higher than in the Open Circuit case. This is depicted
in FIGS. 12 and 13, as noted above, where the measured potential is
measured while stimulation exist, in a no insert electrode
scenario.
[0176] As noted above, there are other physical phenomenon
associated with electrodes that can skew the data set that is
utilized to create the matrix. In view of the above, in an
exemplary embodiment, there is an automatic detection method that
enables the system to be used in a relatively easy manner or
otherwise to provide methods that enable the detection of any
problem in the electrode array vis-a-vis positioning
intraoperatively, as opposed to postoperatively which is defined as
that which includes the utilization of radio graphic imaging or the
like.
[0177] As noted above, some exemplary embodiments of the systems
and methods detailed herein include two different stages: first,
the electrodes that, for example, cannot be inserted or
disconnected from the current source, are discovered. The
information is then processed for a second time in order to detect
tip or electrode fold over or any other anomalous electrode
location scenario to which the teachings detailed herein can be
applicable towards detecting, such as dislocation and bowing, for
example. The methods detailed above can be implemented to do this,
and still further, FIG. 31 presents another exemplary flowchart
according to an exemplary method, where at the commencement of the
detection method, such as the automatic detection method, the first
action that is executed is a determination of the presence and/or
absence of an open circuit and/or a no insert electrode. FIG. 31 is
a subroutine to be executed in the automatic methods detailed
herein. The method represented by FIG. 31 can correspond to method
action 1720 detailed above.
[0178] As can be seen, the automatic system can be arranged so as
to determine whether or not an Open-Circuit and No-Insert-Electrode
scenario exists. In an exemplary embodiment, the procedure
identifies the values in the main diagonal in which the received
potential value is higher than a usual value and/or an expected
value. As referred to before, the main diagonal is compounded by
the measurements done when the stimulus is emitted and received in
the same electrode. Once the problematic electrodes have been
identified, the system classifies the problem, detecting open
circuit or no inserted electrode. FIG. 32 presents an exemplary
flowchart for an exemplary method of detecting open circuit or no
inserted electrodes, which can have utilitarian value or otherwise
can be executed within the methods detailed herein such as those
detailed above. As with the method of claim 31, the method of claim
32 can correspond to method action 1720 detailed above.
[0179] In an exemplary embodiment, once the problematic channel has
been localized and identified, the related data can be marked as
null in the voltage matrix (which can be an action according to
method action 1730, detailed above), making the information
relatively easier process in the next step of the procedure:
anomalous electrode location position detection.
V.sub.i,[i,k]=null
V.sub.i[i,k],j=null Eq. 5
[0180] In an exemplary embodiment, the anomalous electrode location
position detection portion of the system (which can correspond to
method action 1740 detailed above) first starts with analyzing for
the presence or absence of a possible tip fold over, followed by an
analysis for one of the other anomalous location scenarios, such
as, for example, dislocation, buckling, bowing, etc. It is noted
that in at least some exemplary embodiments, the anomalous
electrode location detection procedure could instead start with one
of the other scenarios, such as for example, and not by way of
limitation, dislocation. It is also noted that in an exemplary
embodiment, the analysis can be directed to two or more of these
scenarios at the same time. Still, for the purposes of explanation
only, the tip fold over will be first detailed.
[0181] It is noted that in an exemplary embodiment, the fold over
detection task should confirm three measurements to classify the
voltage matrix as a fold over situation. This is presented by way
of example only and not by way of limitation in the flowchart of
FIG. 33.
[0182] First, in some embodiments, all the values in the matrix are
normalized with the maximum and minimum value:
V ij n = V ij - min ( m v ) max ( m v ) - min ( m v ) Eq . 6
##EQU00003##
[0183] It is noted that while in this exemplary embodiment, this is
presented is the first action of the anomalous electrode location
detection portion of the system. It is to be understood that in an
alternative embodiment, this could be the last action, or can be an
action that is executed in between other actions detailed herein.
It is further noted that, consistent with the teachings detailed
above, in some executions of the anomalous electrode location
detection portion, normalization is not executed, such as, for
example, when determining the presence or absence of bowing. In any
event, for the purposes of this portion of the disclosure, the
first action executed for determining the presence or absence of a
tip fold over condition will be normalization, but again, this can
be executed at the end or anywhere else where such can have
utilitarian value of doing so.
[0184] Tip Fold over detection process executes an identification
of the main diagonal:
V ij n i = j Eq . 7 M V n = [ V 11 n V 22 n V kk n ] Eq . 8
##EQU00004##
[0185] Starting from the main diagonal, in some exemplary
embodiments, the system will look (automatically, at least with
respect to the embodiments that are automated) for one or more or
all of the secondary diagonals that are parallels thereto:
S.sub.d.sup.+=V.sub.u+d,u.sup.n
.A-inverted.u=[i,k],d=[i,k-i]
S.sub.d.sup.-=V.sub.u-d,u.sup.n Eq. 9
[0186] To validate the results, the system calculates the
difference between the minimum and the local maximum value,
discarding, in some exemplary scenarios, the results below a
prefixed threshold, and calculating the number of points that fits
this condition.
max(S.sub.d)-min(S.sub.d).gtoreq.Threshold Eq. 10
[0187] If the maximum and minimum values of subdiagonal, S.sub.i,
commit Eq. 11, the coordinates in the matrix, M.sub.V.sup.n, are
stored. Then, if the obtained coordinates are at least 3, the best
fitting of Eq. 4 is calculated to fit this coordinates.
Least-square fitting method can be applied in order to adapt the
Eq. 4 to the data. Any regime of manipulating the data that can
have utilitarian value and can otherwise enable the teachings
detailed herein can be executed in some embodiments
[0188] Once the fitting is done, the slope of the polynomial
fitting and the root mean squared are calculated. The obtained
slope of the polynomial should be almost 1 in order provide
utilitarian value with respect to warranting its perpendicularity
with the main diagonal.
m = .DELTA. y .DELTA. x 1 1 - .delta. .ltoreq. m .ltoreq. 1 +
.delta. Eq . 11 ##EQU00005##
[0189] The Root Mean Square Value (RMS) can be used to measure how
good the fitting is to the extracted points:
RMS = i = 1 n ( X _ - X i ) 2 n Eq . 12 ##EQU00006##
[0190] The pivoting electrode (the electrode where the electrode
array bends) can then be identified as the one located at the
intersect coordinates of the polynomial fitting and the main
diagonal of the voltage matrix. Thus, based on Eq. 3 and Eq. 4 the
intersection point and the pivoting electrode is
P FO = b ( 1 - a ) Eq . 13 ##EQU00007##
[0191] FIG. 34 depicts different situations of possible
measurements according to an exemplary representation thereof,
presented by way of example only and not by way of limitation. The
solid dots represent the main diagonal and the hollow dots are the
coordinates of the maximum values that have reached the threshold.
The line is the polynomial fitting.
[0192] Again, while the embodiments detailed above have been
directed to fold over, and more specifically, tip fold over, the
above embodiments can be modified so as to detect for other types
of conditions, such as main body fold over, buckling, bowing,
dislocation, etc.
[0193] Consistent with the teachings above, in an exemplary
embodiment, the method actions detailed herein are directed towards
evaluating the array position intraoperatively in an automated
manner. To demonstrate the efficacy of the teachings herein, the
teachings herein were executed and compared to results from
radiological evaluation. In the aforementioned execution, the
patients met the following inclusion criteria: adults and children
with bilateral sensorineural hearing loss, without medical or
psychological conditions that contraindicate undergoing general
anesthesia or surgery or ossification, malformation or any other
cochlear anomaly. All of the patients (recipients) were implanted
with Cochlear Ltd..TM. devices (CI512 and CI532). The study was
approved by the Ethics Committee of the Complejo Hospitalario
Universitario Insular Materno Infantil de Gran Canaria.
[0194] The surgical procedure for the cochlear implantation
followed the same scheme as in daily routine cochlear implantation:
retro auricular incision, mastoidectomy, tympanotomy, cochleostomy
or round window opening, electrode insertion, intraoperative
measurements and closing. Intraoperative measurements were executed
to stage the fold over detection system and a Fluoroscopic imaging
(BV Pulsera system Philips). During the surgery, if there was no
presence of fold over, the surgery was completed. If there was an
indication of fold over, a reinsertion of the electrode array, at
least in the case of CI532, was done and the results re-evaluated.
Data acquisition for the fold over detection system was done on a
Python script developed by using the Nucleus Implant Communicator
(NIC).TM. library, provided by Cochlear Ltd..TM., which enabled the
performance of voltage matrix acquisition. In order to validate the
results, the University Hospital of Las Palmas de Gran Canaria made
use of a prototype of the automatic system which executed some of
the teachings detailed herein, which was developed in Visual Studio
and Python. The prototype was responsible for representing in a
clear and simple way the evaluation of the insertion of the implant
in the cochlea from the analysis of the voltage matrix.
[0195] FIG. 35 depicts different outputs of an exemplary embodiment
of the automated system, which can be displayed on a computer
monitor. In case of fold over detection, the graphical user
interface (GUI) indicates the fold with a red background, and the
pivoting electrode in blue. In no insert case, the affected
electrodes are highlighted in yellow, while the open circuit
electrodes are marked in red. Of course, in alternate embodiments,
such can be provided in a different manner, such as utilizing
different color schemes and the like. In an exemplary embodiment,
there can be an anomalous electrode location automatic diagnosis
system, which can be executed utilizing a personal computer or the
like with the inputs and outputs to/from the cochlear implant as
will be described in greater detail below, or otherwise executed
utilizing a dedicated medical device diagnostics equipment that
receives inputs and outputs to from the cochlear implant, and the
system can have a display, such as a computer display, and the GUI
thereof can indicate the presence of fold over (red background) and
the pivoting point (blue electrode) and/or a N-Insert (highlighted
in yellow) and/or an Open-Circuit (highlighted in red) or any other
type of physical phenomenon according to the teachings detailed
herein and variations thereof.
[0196] Also, it is noted that while the embodiment of FIG. 35
presents a relatively sophisticated output, in an alternate
embodiment, a less sophisticated output can be provided, such as,
for example, the simple elimination of a light or the like to
indicate the presence of tip fold over and/or dislocation and/or
electrode non-insertion. Alternatively and/or in addition to this,
the generation of an audible tone to indicate the presence of tip
fold over and/or dislocation and/or electrode non-insertion can be
utilized. In an exemplary embodiment, different colored lights or
even different lights entirely can be utilized to indicate the
various anomalous electrode location scenarios. Such is also the
case with respect to the tones that could be generated by a
machine. By way of example, a first tone/sound can be generated to
indicate electrode dislocation, a second tone or sound of a
different type can be generated by machine to indicate tip fold
over, a third tone or sound of a different type can be generated by
machine to indicate bowing, a fourth tone or sound of a different
type can be generated by machine to indicate buckling, etc. Such is
also the case with the lights or other visual indicators--different
colored lights were different lights entirely can be illuminated.
In this regard, by way of example only and not by way of
limitation, in an exemplary embodiment, upon the execution of one
or more or all of the method actions detailed herein, upon a
determination by the system that an anomalous electrode position
scenario exists, the methods can be utilized to automatically
trigger a machine to output an indication to the surgeon or other
healthcare professional that such an anomalous electrode position
exists. Indeed, in an exemplary embodiment where the insertion is
executed utilizing a robotic and/or a semi-robotic device, such as
an insertion guide with an actuator that drives the electrode array
into the cochlea, the methods detailed herein can be executed upon
a determination that an anomalous electrode position exists, the
methods can be utilized to cause the actuator to retract the
electrode array at least partially out of the cochlea, and then
begin the insertion process again. Still further, in an exemplary
embodiment, the methods can be utilized to halt insertion of the
electrode by stopping the actuator. Still further the methods could
be used to control the speed, angle or rotation of the actuator. Of
course, in some embodiments, the teachings detailed herein are
directed towards providing an indicator to the surgeon. In an
exemplary embodiment, an illumination device or the like can be
present on the aforementioned insertion guide. The methods detailed
herein can be utilized to execute the elimination of a light or the
like on the insertion guide that is clearly visible to the surgeon
to provide an indication there to of the anomalous electrode
location.
[0197] The statistical analysis to evaluate the performance of the
implemented algorithm was a confusion matrix (false positive--false
negative). The results were also correlated with radiological
findings. Each column of the matrix represents the output of the
classifier while each row represents the real state of the
electrode array. The false positive and negative rate, the
accuracy, sensitivity and specificity of the system can be then
calculated. In a sample of 80 patients, 100 implanted ears, was
collected during a 16 months period, of whom 57% were men and 43%
were women. The patients' age range from 1.5 to 77 years old, with
an average of 42 years and a standard deviation of 13.12 years.
57.5% of the subjects were adults and 42.5% children. Simultaneous
bilateral implantation was performed on the 76.4% of the children.
In adults, 6.5% of cases were a re-implantation and 34.78%
corresponded to second implanted ears. 18% of the patients were
implanted with CI512 (n=18), 71% with CI532 (n=71) and 11% with the
CI422/CI522 (n=11). In the operating theatre, the voltage matrix
and its automatic diagnosis output was collected and compared with
a fluoroscopic image, as seen for example in FIG. 36 and FIG. 37,
which were sequentially obtained, where FIG. 36 presents a fold
over case with a voltage telemetry matrix of the fold over
position, and FIG. 37 presents a correct placement image; with a
voltage telemetry matrix of the correct placement.
[0198] Then, an expert surgeon evaluated the fluoroscopic images
associated to every voltage matrix and indicates the presence or
lack of a Tip Fold over in order to compare the results. (Again, in
an exemplary embodiment of the teachings herein, there is no expert
evaluation.)
[0199] A confusion matrix was created to evaluate the automatic
Fold over detection system. The false positive and false negative
rate was 0, sensitivity 100%, specificity 100%, accuracy 100%
TABLE-US-00001 TABLE 1 Confusion matrix. Automatic System Positive
Negative Expert Positive 6 0 Negative 0 94
[0200] The presence or absence of fold over (100 cases) was
correctly detected. The total diagnosis time took an average of
63.78 seconds in all subjects (see FIG. 38, detailing the
acquisition time of the voltage telemetry matrix and the automatic
diagnosis) instead of 21 minutes of the fluoroscopy imaging. The
entire fold over detections were produced on electrode array CI532
.TM., as seen in FIGS. 39A-D, and the pivoting electrodes are
detailed below:
TABLE-US-00002 TABLE 2 Pivoting electrode in Fold over detections
Pivoting Case Electrode Fold over 1 11 Electrode fold over 2 11
Electrode fold over 3 16 Tip fold over 4 17 Tip fold over 5 19 Tip
fold over 6 8 Electrode fold over
[0201] In some embodiments, the teachings detailed herein and/or
the results of the methods are executed without using neural
response telemetry, without using Ecog, without using imaging
systems, and/or without using standard impedance spectrography. The
teachings detailed herein can enable an evaluation of the
positional arrangement of the electrode array to determine the
presence and/or absence of anomalous electrode locations within few
seconds or a few minutes, without any side effects to the patients
or surgical team, such as by way of example only and not by way of
limitation, radiological testing.
[0202] In some embodiments of the teachings detailed herein, the
methods are executed with respect to the insertion of a
perimodiolar array/curved array, with the goal of having an array
that is in contact with the perimodiolar wall upon full
implantation of the array.
[0203] Teachings detailed herein can enable the division of the
fold over between tip or electrode fold over. This differentiation
can be based on how aggressive is the fold over. Such cases that
the fold over is produced on the tip of the electrode (involve only
3-5 electrodes) are called Tip Fold over. The other situations
where we have a complete Fold over, the electrode array folded in
half, can, in some instances, provide a more significant impact on
the cochlear implant outcome, and in some instances, require
re-implantation. Indeed, in an exemplary embodiment, the teachings
detailed herein are utilized to determine whether the anomalous
electrode position is a tip fold over or an electrode fold
over/complete fold over, and an indication is provided to a
surgeon, where the surgeon can make a determination as to attempt
to re-implant or otherwise reposition the electrode array based on
such. In an exemplary embodiment, the surgeon does not attempt to
reposition the electrode array, when such an indication is provided
that it is a tip fold over, while in some exemplary embodiments,
the surgeon does attempt to reposition the electrode array in a
scenario where it is a complete fold over. In an exemplary
embodiment, the automated system can be configured to analyze the
given scenario and provide an automatic indication to the surgeon
as to whether or not the surgeon should attempt to reposition the
electrode array. In an exemplary embodiment of this exemplary
embodiment, a database of previous cases and resulting performance
can be utilitarian with respect to comparing the data to determine
whether or not the surgeon should attempt to reposition the
electrode array. In an exemplary embodiment, the algorithm can
determine whether or not it is simply a tip fold over or a complete
fold over, and the system can indicate that the electrode array
should be repositioned in the case of a determination that it is
the latter and not the former. Still further, in an exemplary
embodiment, an automated system can automatically execute the
re-positioning.
[0204] According to at least some exemplary embodiments herein,
there is provided an automatic system for intra-operative fold over
detection and/or dislocation and/or buckling and/or bowing that has
90, 91, 92, 93, 94, 95, 96, 97, 98, 99 and even in some embodiments
100% accuracy, at least with respect to determining that such
exists, without false positive or negative indications. In at least
some exemplary embodiments, the teachings detailed herein provide a
system that enables surgically, without imaging tests, the
detection of the correct insertion of the implant. It allows
working in patients without neural responses, eliminating imaging
tests, with the utilitarian value that brings the patient to avoid
radiation and also decreasing surgical time, especially in
simultaneous bilateral implantations.
[0205] In view of the above, in an exemplary embodiment, there is a
system, comprising, a control unit configured to receive telemetry
from an implantable system of a cochlear implant electrode array
(described in greater detail below) and determine a feature related
to a global position of the electrode array relative to an interior
of the cochlea of the recipient (e.g., a tip fold over, bowing,
buckling--the overall state of the array relative to the structure
inside the cochlea as opposed to merely individual
locations/relative locations of individual parts of the array)
wherein the telemetry includes data based on electrical phenomenon
associated with the electrode array. In an exemplary embodiment,
the control unit can be executed utilizing a personal computer or
the like or some other device that includes a processor. The
control unit can be located remote from the surgeon/surgical room
(in some embodiments, in signal communication there with via the
Internet or the like), or can be located there with. The control
unit is further configured to automatically analyze the data to
determine whether or not portions of the data are acceptable for
use in determining the feature, and the control unit is configured
to automatically modify the data to at least one of eliminate or
replace the portions of the data that are deemed not acceptable for
use in determining the feature, and use the modified data to
determine the feature related to the global position of the
electrode. In an exemplary embodiment, the aforementioned control
unit can be configured to execute one or more or all of the method
actions detailed herein, and thus can include a program product or
otherwise can include a non-transitory computer readable media
having recorded thereon, a computer program for executing at least
one or more or all of the method actions detailed herein and/or
variations thereof, the computer program including code for
executing one or more or all of the method actions detailed herein,
which code can be a combination code or a code that is specific to
each of the individual method actions detailed herein, etc.
[0206] In an exemplary embodiment, the control unit is configured
to provide output that enables a virtual indication of the feature
to a healthcare professional proximate the cochlear implant
electrode array while the healthcare professional has direct access
to the implantable system (e.g., in the operating room). To be
clear, the system need not be configured to actually provide the
virtual indication, only that the output be such that the virtual
indication is enabled. Again, in an exemplary embodiment, the
teachings detailed herein can be utilized with a remote unit that
is in signal communication with a hospital the like by the
Internet. The hospital can have the component that can provide the
indication to the recipient. Indeed, in an exemplary embodiment,
the output can be directed over phone lines and be heard over a
speakerphone that is in the operating room, in some such exemplary
embodiments. Again, in an exemplary embodiment, the methods and
actions detailed herein can enable the activation of a machine, in
an automated manner, that will output a signal that will cause a
machine to provide an indication to the surgeon. Still further, the
teachings detailed herein can enable automated insertion and
reinsertion and adjustment of the location of the electrode array,
such as in an embodiment that utilizes a robotic device, where the
control unit is located many miles, and in some instances, on
another continent, from where the robotic device is located/the
surgery is execute.
[0207] In an exemplary embodiment, the feature is a fold over (tip
or otherwise) of a tip of the cochlear electrode array, and the
control unit is configured to provide an indication of the
occurrence of the fold over of a tip of the cochlear electrode
array while the healthcare professional has direct access to the
implantable system. Also, the control unit can be configured to
provide an indication of the location of the fold over of the
cochlear electrode array while the healthcare professional has
direct access to the implantable system.
[0208] Consistent with the teachings above, the system can be
configured to provide the aforementioned indication at a rate that
is statistically more reliable than a single X-ray of the cochlear
of the recipient with the electrode array therein. Also, the
control unit can be further configured to automatically analyze the
data to determine whether or not portions of the data are
indicative of an open circuit, a short circuit, a bubble proximate
the electrode array, an electrode not in the cochlea, an electrode
conditioning phenomenon or a detrending phenomenon, and deem the
data unacceptable for use if the data is indicative thereof, again,
consistent with the teachings detailed above. Also, the control
unit is configured, in some embodiments, to establish at least a
virtual matrix of electrical readings based on the electrical
phenomenon, wherein the matrix has rows corresponding to target
electrodes and columns corresponding to measurement electrodes, or
vice versa and/or adjust and/or provide new components of the
matrix for data that is determined to be unacceptable for use in
determining the feature; and/or determine the feature by analyzing
the matrix. Alternatively or in addition to this, the control unit
is configured to normalize the components of the matrix after any
adjustment and/or providing of new components.
[0209] It is noted that in at least some exemplary embodiments, the
control unit is configured to execute one or more or all of the
method actions detailed herein and/or variations thereof. In an
exemplary embodiment, the control unit includes a non-transitory
computer readable media having recorded thereon, a computer program
for executing the methods and/or the method actions detailed
herein, that computer program including code for doing so.
[0210] It is noted that at least some of the teachings detailed
herein can be executed in conjunction with one or more or all of
the method actions, devices and/or systems disclosed in U.S. Patent
Application Publication No. 20120316454 to Paul Carter, filed on
2011 Jun. 10, the contents of which are hereby incorporated by
reference in their entirety. Accordingly, in an exemplary
embodiment, there is a method that includes executing one or more
or all of the method actions disclosed in the '454 patent
publication as well as including executing one or more of the
method actions disclosed in this application. In this regard, in an
exemplary embodiment, the teachings detailed herein can be utilized
to condition the data (and obtain the data that is required for the
conditioning) that is obtained by executing one or more or all of
the method actions in the '454 patent publication followed by
subsequent processing as disclosed in the '454 patent publication.
It is also noted that at least some of the teachings detailed
herein can be executed in conjunction with one or more or all of
the method actions, devices and/or systems disclosed in U.S. Patent
Application No. 62/476,295 to Nicholas Charles Pawsey, filed on
Mar. 27, 2017, in the USPTO, the contents of which are incorporated
herein by reference in their entirety. Accordingly, in an exemplary
embodiment, there is a method that includes executing one or more
or all of the method actions disclosed in the '295 patent
application as well as including executing one or more of the
method actions disclosed in this application. In this regard, in an
exemplary embodiment, the teachings detailed herein can be utilized
to condition the data that is obtained by executing one or more or
all of the method actions in the '295 patent application followed
by subsequent processing as disclosed in the '295 patent
application. Moreover, in an exemplary embodiment, the teachings of
the '295 that are directed towards determining the distance between
the electrode array and the modiolus wall can be utilized to obtain
data to identify a bowing condition. By way of example only and not
by way of limitation, in an exemplary embodiment, if the distances
as a mean, median and/or mode, or as an individual instance, are
(is) above a certain value (which could be above zero, in some
embodiments), where such distances are determined utilizing the
teachings of the '295 patent, a determination can be made that the
electrode array is bowing. Also, the data that is utilized to
determine the distances can be conditioned according to the
teachings detailed herein prior to executing the analysis that
provided the distance determination.
[0211] FIG. 40 depicts an exemplary embodiment of a cochlear
electrode array insertion guide 700. In an exemplary embodiment,
the insertion guide 700 corresponds to that of the insertion guide
200 detailed above, with the exception of the addition of electrode
704, and the modifications to the tool so as to support the
electrode and the associated components thereof (e.g., electrical
leads 706 (only the "distal" portion of the lead (distal relative
to the tool 800) is depicted, the "break` being conceptual),
etc.--more on this below). Accordingly, FIG. 40 depicts a cochlear
electrode array insertion guide comprising an array guide (e.g.,
the insertion guide tube (210 of FIG. 2)) and an active functional
component (e.g., electrode 704). Some additional details of some
exemplary functional components, including some exemplary active
functional components, will be described in greater detail below.
However, it is briefly noted at this time that not all embodiments
of the cochlear electrode array insertion guide include an
intracochlear portion. In this regard, FIG. 40 depicts a tool 700
that includes an intracochlear portion 710. This is the portion to
the right of stop 204/the portion on the distal side of stop 204
(distal relative to the entire insertion guide). Conversely, FIG.
41 depicts a tool 800 that does not include an intracochlear
portion. Instead, stop 204 is configured to be placed against the
outside of the cochlea such that the passageway through the tool
through which the electrode array is passed is aligned with the
pertinent window and/or cochleostomy such that no parts of the tool
800 enters the cochlea.
[0212] It is noted that while the teachings detailed herein with
respect to extra functionality of the insertion guide are based on
the insertion guide detailed above with respect to FIGS. 5A-6D,
these teachings can be applicable to other types of insertion
guides. Indeed, as will be detailed below, some embodiments of the
insertion guides do not have an intracochlear portion at all.
Accordingly, the teachings above with respect to FIGS. 5A-6D serve
as but one example of an insertion guide that the following
teachings can be utilized in conjunction therewith.
[0213] With reference back to FIG. 40, the exemplary active
functional component can be an electrode (read or energizing,
etc.).
[0214] The embodiments of FIGS. 40 and 41 are such that the
electrode 704 abuts the outside of the cochlea during use so as to
establish physical contact with the outside of the cochlea. FIG. 42
depicts an exemplary scenario of use, where element 910 is the wall
of the cochlea that separates the middle ear cavity from the inner
cavity. In an exemplary embodiment, electrode 704 abuts the
cochlear promontory. In an exemplary embodiment, electrode 704
abuts the round window and/or oval window. With respect to the
"and/or" it is noted that while the embodiments depicted herein
indicate a single electrode, in alternative embodiments, two or
more electrodes can be utilized in an array such that one contacts
the oval window and the other contacts the round window.
[0215] In any event, it is again noted that the electrode can be
located anywhere on the guide that the electrode can have
utilitarian value with respect to establishing a read and/or a
stimulation electrode according to the teachings herein (or a
reference electrode).
[0216] While the embodiments detailed above have focused on the
electrode being located entirely outside the cochlea (e.g.,
entirely inside the middle ear), in an alternative embodiment, the
electrode is located inside the cochlea during use. FIG. 43 depicts
an exemplary insertion regime utilizing exemplary electrode array
insertion guide 1000 where the electrode is located entirely in the
inner cavity (in the cochlea) when the insertion guide is fully
inserted into the inner ear cavity. Still further, FIG. 44 depicts
an exemplary insertion regime utilizing exemplary electrode array
insertion guide 1100 where the electrode being is located in the
wall that separates the middle ear cavity from the inner ear cavity
when the insertion guide is fully inserted into the inner ear
cavity. In an exemplary embodiment, a portion of the electrode 704
is located in the middle ear cavity, and another portion of the
electrode 704 is located in the wall 910 and/or in the inner cavity
when the insertion guide 1100 is fully inserted into the cochlea.
In an exemplary embodiment, the guide is such that the entire
electrode 704 is located in the wall 910 (i.e., in the hole through
the wall) when the insertion electrode 1100 is fully inserted into
the inner ear cavity. That is, no part of the electrode is located
in the middle ear cavity where the inner ear cavity (where, for the
purposes of this paragraph only, the volume corresponding to the
hole that is formed in the cochlea so that the array can pass from
the middle ear cavity to the inner ear cavity is neither in the
middle ear cavity nor in the inner ear cavity). In an exemplary
embodiment, the guide is such that a portion of the electrode 704
is located in the wall 910 when the insertion guide 1100 is fully
inserted into the inner ear cavity, and a portion of the electrode
is located in the inner ear cavity when the insertion guide is
fully inserted into the inner ear cavity.
[0217] FIG. 45 depicts an insertion guide 2900 that is in wireless
communication via element 3810 with a remote component 560, which
could be a test unit or a control unit as disclosed further
below.
[0218] As briefly noted above, in at least some exemplary
embodiments, some exemplary insertion guides can include a
self-contained measurement system. FIG. 46 depicts such an
exemplary embodiment of an insertion guide 3900. Insertion guide
3900 contains a complete measurement system. As can be seen, the
insertion guide 3900 further includes a reference electrode 2404,
which is in signal communication with the electrical leads of the
system via lead 2416. Lead 39061 extends from the connector to test
unit 3960, which can correspond to test a test unit configured to
executes one or more or all of the test teachings herein, and can
be a personal computer programmed to execute such. Test unit 3960
is in signal communication with communication unit 3810 via lead
39062. Communications unit 3810 can be in wireless communications
with remote device 3960. In an exemplary embodiment, the remote
device 3960 is a data storage device/data recording device that
records the data transmitted via the communications unit 3810. For
example, 3960 can be a desktop and/or a laptop computer having
memory therein to record the data. In an alternate embodiment,
device 3960 can be a control unit or the like, again such as a
computer, that can control measurement system of the guide 3900.
That said, in an exemplary embodiment, the guide 3900 includes an
activation switch or the like so that the system can be activated
and/or deactivated by the surgeon or other healthcare
professional.
[0219] It is noted that in an exemplary embodiment, reference
electrode 2404 can be configured so as to clamp or otherwise mount
onto one or more of the reference electrodes of the receiver
stimulator of the cochlear implant. In an exemplary embodiment,
instead of reference electrode 2404 at the end of lead 577, there
is an alligator clip or the like that clips onto the "can" of the
receiver stimulator of the cochlear implant, which has an
electrical configuration of a reference electrode/sink of the
cochlear implant. That said, in an alternate embodiment, such can
be placed into electrical communication with the so-called hardball
electrode of the cochlear implant electrode array. That said, in an
alternate embodiment, a more sophisticated connection mechanism can
be utilized, such as a snap coupling or the like on the can. Also,
it is noted that while the electrodes 704 and 1904 are depicted as
being on the outside of the cochlea during insertion, in an
alternate embodiment, the electrodes (one or more or all) can be
located on the inside the cochlea in alternate embodiments where
the electrodes are different than that depicted in FIG. 46.
[0220] It is also noted that while the embodiment of FIG. 46
utilizes a reference electrode 2404, in an alternate embodiment,
the reference electrode can be any of the electrodes of the
insertion guide detailed above. In an exemplary embodiment, any of
those electrodes can be placed into electrical communication with
the can of the cochlear implant and/or the hardball, or any other
electrode of the cochlear implant, again by way of, for example,
alligator clip or other fastening mechanism that can permit
electrical communication from the electrode(s) of the insertion
tool to the cochlear implant. Such can have utilitarian value with
respect to establishing a reference electrode closer to the source
and sink electrodes that are utilized for stimulation.
[0221] FIG. 47 depicts another exemplary embodiment of an insertion
guide that has a functionality beyond that of an electrode array
support/an electrode array insertion device. Particularly, the
embodiment of FIG. 47 depicts a portion of the insertion guide tube
at the stop 204 where a sensor 4101 is located in the wall 658 of
the tube, although in other embodiments, the sensor 4101 is located
on the inside wall of the tube and in other embodiments, the sensor
4101 is located on the outside wall of the tube. In this exemplary
embodiment, the sensor is configured to sense or otherwise detect
individual electrodes in the array as they pass by the sensor as
the electrode array is inserted through the lumen 640 into the
cochlea, and output a signal via lead 1410 indicative of at least
one of an electrode passing the sensor 4101 or, in a more
sophisticated embodiment, the speed of the electrode/electrode
array passing by sensor 4101. In an exemplary embodiment, the
sensor 4101 can be a sensor that utilizes capacitive sensing. In an
exemplary embodiment, it could be a Hall effect sensor. In some
embodiments, the sensor could be a sensor that comes into direct
contact with the electrodes of the electrode array. In an exemplary
embodiment, there is a system that receives the signal from lead
1410 and outputs data indicative of the insertion speed of the
electrode. In an exemplary embodiment, the system can be a personal
computer with an algorithm that analyzes the signal 4110, and
outputs data to the surgeon. Exemplary output can be output by a
speaker or the like indicating the speed of the insertion of the
electrode array. Exemplary output can be output by a visual device
indicating the speed of insertion of the electrode array. Exemplary
output can correspond to the speed of insertion, a go/no go data
package (e.g., insertion too fast/insertion speed fine). Such can
be done via audio and/or visual devices. For example, a green light
can indicate acceptable speed and a red light can indicate an
unacceptable speed. Moreover, the system can be binary. The
activation of the light will indicate that the speed is too
fast/the audio indication (which could be a buzzer or a tone, etc.)
activates when the insertion speed is too fast. The alternative
could also be the case. The tone and/or light can be activated
while the insertion speed is acceptable, and the tone or light is
deactivated when the insertion speed is unacceptable. It will be
noted that these indicators can also be utilized to indicate other
sensed phenomenon or otherwise detected phenomenon as detailed
herein.
[0222] FIG. 48 depicts a portion of an exemplary insertion guide
that is configured to enable testing for an open circuit between
two or more electrodes of the electrode array as the array passes
through the lumen 640. Briefly, component 4401 is made of a
conductive material that essentially "shorts" two electrodes of the
electrode array as they pass by in contact with the component 4401.
As will be detailed below, component 4401 can be a flexible
component so as to provide a compressive force on the outside of
the electrode array so as to establish sufficient electrical
conductivity between an electrode, component 4401, and another
electrode. In general terms, FIG. 49 depicts a quasi-functional
diagram of a portion of electrode array 145, depicting electrodes
1, 2, and 3, which are respectively connected to leads 11, 12, and
13, which leads extend from the respective electrodes to the
proximal end of the electrode array assembly, and then to a
receiver/stimulator thereof. While only three electrodes and three
leads are depicted in FIG. 49, it is to be understood that in at
least some embodiments, more electrodes and more leads are present
in electrode array 145. Only three electrodes and only three leads
are depicted in FIG. 45 for clarity.
[0223] In isolation, without any contact with any outer material
other than air, to test for a short, a source of current is applied
to any one of the leads 11, 12, or 13. If current is detected (this
phenomenon is described generally--in at least some exemplary
embodiments, the "detection" corresponds to a given functionality
of the receiver/stimulator that can be telemetrically transmitted
and analyzed--more on this below) at any one of the other leads 11,
12, and/or 13, a determination can be made that a short exists.
This is because the impedance between the electrodes 11, 12, and 13
should be relatively high (the material connecting the electrodes
148 is typically made of silicone). The leads 11, 12, and 13 are
insulated from one another and from the electrodes other than the
respective electrodes associated with the respective leads.
[0224] Conversely, to detect for an open, in the absence of contact
with any other material other than air, because of the high
impedance between the respective electrodes, and the aforementioned
electrical insulation, there is nothing to close the circuit
between a source of electrical current applied to one lead, and a
detector (again, this is used generally--more on this below)
located at any of the other leads.
[0225] Accordingly, in an exemplary embodiment, the apparatus 4401
is configured to enable testing for an open circuit between two
electrodes by utilizing conductive material that is sufficiently
conductive to test for an open circuit when placed into contact
with two or more electrodes of the electrode array 144. In use,
component 4401 extends a sufficient distance into the lumen 640 and
has sufficient length such that it can contact two electrodes as
the electrode array passes by component 4401. In an exemplary
embodiment, the entire component 4401 is made of a requisite
conductive material. In an exemplary embodiment, only a portion
thereof is made of the requisite conductive material. By way of
example only and not by way of limitation, at least the bottom
surface (the surface that faces the electrodes/the surface that
comes into contact with the electrodes) can be made of the
requisite conductive material, or at least coated with the
requisite material or otherwise the requisite material is attached
to the interior thereof). In an exemplary embodiment, only a
portion of the component 4401 is made of the requisite conductive
material. Any arrangement that can enable the testing of an open
circuit while electrode array assembly is being passed can be
utilized in at least some embodiments.
[0226] In an exemplary embodiment, the material of the component
4401 and/or other material forming a portion of the component 4401
and/or any other material that enables testing for an open circuit
has a "midrange" impedance, or at least enables the establishment
of a midrange impedance between two or more electrodes, such that
both testing for an open circuit and testing for a short circuit
can be implemented. In other exemplary embodiments, the component
4401 has a relatively high range impedance.
[0227] In an exemplary embodiment, the component 4401 is configured
to provide a controlled impedance between two or more electrodes
that will enable at least testing for an open circuit between two
electrodes, if not both testing for an open circuit and testing for
a short circuit between two electrodes.
[0228] Thus, in an exemplary embodiment, the component 4401 is
configured to enable two types of conductivity testing of the
electrode array (e.g., testing for an open circuit and testing for
a short circuit) in some embodiments.
[0229] FIG. 50 depicts an exemplary conductive apparatus 4622 in
the form of an elongate cylinder having a passage 4624
therethrough, wherein the passage 4624 is sized and dimensioned to
receive the electrode array 145 therein such that at least two
electrodes of the electrode array 145 contact the interior walls of
the passage 4624 to establish electrical conductivity between the
electrodes. In an exemplary embodiment, the conductive apparatus
4622 is configured such that an impedance between any two locations
on the interior surface of the passage 4624 within a distance
corresponding to the distance between two electrodes of the
electrode array 145 that will be inserted or otherwise located
within passage 4624 is less than about 500 ohms (or any other value
that will enable testing for an open circuit between two
electrodes--more on this below). In this regard, it is noted that
all disclosures of impedance and related phenomenon detailed herein
both correspond to the structure being described, and how the
structure is arranged or otherwise used. That is, because impedance
varies both with respect to distance and with respect to material
type (along with some other features) and it is the resulting
impedance that imparts utilitarian value on to the teachings
detailed herein, as opposed to the specific impedance of a given
material or the like, any disclosure herein regarding material
properties also corresponds to the functionality of the resulting
apparatuses when utilized according to the teachings detailed
herein and/or variations thereof.
[0230] FIG. 53 depicts the conductive apparatus 4622 located in the
insertion guide tube 610 of the insertion guide. In an exemplary
embodiment, the interior of the conductive apparatus at the ends
thereof is rounded so as to provide a smooth interface between the
interior wall of the tube wall 658 and the "bump up" that is the
interior of conductive apparatus 4622. That is, because the
interior of conductive apparatus 4622 is proud of the interior wall
of the tube wall 658, ramping can be used so as to avoid binding or
otherwise catching the electrode array one the edges of the
conductive apparatus 4622.
[0231] Briefly, the embodiments utilizing apparatus 4622 and
variations thereof to "short" two electrodes rely on, in some
embodiments, the ability of the receiver/stimulator of the cochlear
implant to provide an electrical signal to one of the electrodes
and sense a voltage and/or current at the other of the electrodes.
In an exemplary embodiment, a device is in inductance communication
(or any other applicable communication format that will enable the
teachings detailed herein and/or variations thereof to be
practiced) with the receiver/stimulator of the cochlear implant so
as to communicate data therefrom indicating whether or not an open
circuit is present. Indeed, in an exemplary embodiment, the device
that is in inductance communication with the receiver/stimulator is
the device that initiates the current to one of the electrodes and
the first instance. In an exemplary embodiment, the communication
can correspond to the communication that transcutaneously takes
place between the external component 142 and the implantable
component 144 vis-a-vis the system of FIG. 1. That is, in an
exemplary embodiment, the communication from the
receiver/stimulator and/or to the receiver/stimulator can be
executed utilizing techniques that are the same as, or at least
analogous to, the transcutaneous communication that takes place
while the cochlear implant 100 is implanted in a recipient fully
and completely beneath the skin.
[0232] FIG. 52 depicts a view looking down the longitudinal axis of
the conductive apparatus 4622. It is noted that the geometric
shapes presented in these FIGs. are but exemplary. Any
configuration that will enable the teachings detailed herein and/or
variations thereof to be practiced can be utilized. FIG. 5I also
depicts a view looking down, where, with respect to a cross-section
of an array, an electrode can be seen.
[0233] It is further noted that while the embodiment depicted in
the figures are depicted as a monolithic component (in an exemplary
embodiment, the entire body 4622 is made from a conductive
material, and thus conductive apparatus 4622 is a tube or cylinder
of conductive material), in an alternative embodiment, the
conductive apparatus 4622 can be a multilithic component. Indeed,
in an exemplary embodiment, the walls of the passageway 4624 can be
coated with a conductive material (e.g., gold), and the remainder
of the conductive apparatus 4622 is made of a relatively
nonconductive material (e.g., rubber, silicone, etc.). In this
regard, for embodiments where the conductor used to test for the
open circuit is movable in and out of position, the impedance range
of the conductor can be very low.
[0234] It is noted that in an exemplary embodiment, the entire body
4622 and/or a portion thereof (e.g., the portion making up the
walls of the passageway 4624) is a conductive foam or conductive
polymer. Typically, this is foam or polymer containing conductive
elements (e.g., loaded with silver, gold, carbon, etc.). This can
have utilitarian value with respect to deforming around the
electrode array as the electrode array passes through body 4622.
Accordingly, such can have utilitarian value with respect to
contracting as the localized width of the electrode array relative
to body 4622 becomes wider as the electrode array is passed
therethrough during insertion of the electrode array.
[0235] FIG. 5I depicts the view of FIG. 50, with the addition of
the electrode array 145 being located in the passage 4624 (the
array is shown in cross-section). More particularly, the view of
depicts a cross-sectional view of an electrode array 145 taken at a
location where electrode 1 is located. FIG. 54 presents FIG. 51 in
greater context, which depicts a side view of a cross-section
through the conductive apparatus 4622 with the electrode array 145
located therein.
[0236] As can be seen, the electrodes are in contact with the inner
surface of the passageway 4624. In this embodiment, the contact is
sufficient to provide electrical conductivity from electrode 1 to
electrode 2 and/or electrode 3 such that testing for an open
circuit between one of these electrodes can be implemented.
Corollary to this is that the conductive apparatus 4622 is
configured to maintain the requisite contact to enable testing for
an open circuit between two or more of the electrodes and/or be
placed and held in that configuration for such testing to be
executed. In an exemplary embodiment, conductive apparatus 4622 is
made of a conductive foam material, wherein an interference fit is
established between the electrode array 145, and thus the
electrodes 148, and the inner surface of the passage 4624. In an
exemplary embodiment, the interference fit ensures that sufficient
contact will be made between the inner surface of the passage 4624
and the respective surfaces of the electrodes 148. In an exemplary
embodiment, the use of foam ensures or otherwise substantially
lessens the chance that the array 145 will be damaged due to
contact between the array and the conductive apparatus 4622. This
will be described in greater detail below.
[0237] FIG. 55 presents a functional representation of the
functionality of the conductive apparatus 622, where hypothetical
leads 1010 and 1020 are located between electrodes 1 and 2 and
between electrodes 1 and 3, respectively. Also shown is
hypothetical lead 1030, which is located between electrodes 2 and
3. These leads place the various electrodes into electrical
conductivity with one another so that testing for an open circuit
can be executed. Also depicted by way of black box format is a
current generator/detector 1040, which is configured to apply
current to one or more of the leads 11, 12, 13, and detect a
current (if there is no open circuit) at one or more of the other
of leads 11, 12, 13. The current generator/detector 1040 is but a
functional representation of the operation of the
receiver/stimulator 180 and/or a test device. That said, in some
alternate embodiments, current generator/detector 1040 can be an
ohmmeter and/or a multimeter, albeit one adapted for the types of
voltage and current suitable for testing of a cochlear electrode
array or other array to which the teachings detailed herein are
applicable.
[0238] Briefly, in an exemplary embodiment, a current is applied by
current generator/detector 1040 to lead 12. Current
generator/detector 1040 "looks" for a current at either or both of
leads 11 and 13. (In an exemplary embodiment, the insertion guide
includes a generator configured to generate current at a programmed
amount through lead 12 and return it through one or all of the
remaining electrodes. In an exemplary embodiment, the guide
provides an output indicative of voltage required to drive this
amount of current. In an exemplary embodiment, if the voltage is
above a certain threshold, it is deemed an open circuit. Otherwise,
it is assumed the current is flowing and thus this circuit is
closed.) Because the conductive apparatus 622 has placed electrode
2 into electrical conductivity with electrodes 1 and 3 via
hypothetical leads 1010 and 1030, a current should register at one
or both of leads 11 and 13 (or only one of the leads if only one of
the hypothetical leads 1010 and 1030 or present) thus indicating
that there is no open circuit between current generator detector
1040 and electrode 2.
[0239] Note that by "looking" for a current at two or more leads,
the scenario where an open circuit exists with respect to one of
the other leads, which open circuit could give a "false-negative"
with respect to the lead under test can be accounted for in an
exemplary embodiment. For example, if lead 12 is being tested (or,
more precisely, testing for an open circuit is being performed
between current generator/detector 1040 and electrode 2), and if
only one lead, such as lead 11, was being utilized for the test,
failure to detect a current by current generator/detector 1040 at
lead 11 would not necessarily indicate a break for an open circuit
associated with lead 12. This is because lead 11 could have failed.
However, if a current is detected at lead 13 but not lead 11, it
can be surmised that lead 12 is in proper working order, and lead
11 has experienced a failure mode. That is, it can be extrapolated
or otherwise inferred that lead 11 has failed in some manner (i.e.,
the open circuit is between current generator/detector 1040 and
electrode 1). In this regard, exemplary embodiments include
algorithms to more quickly test a plurality of circuits in view of
the fact that deductive logic can be utilized when more than two
electrodes are placed into electrical conductivity with one another
via conductive apparatus 622.
[0240] Note further that to test for a short circuit, the
hypothetical leads are removed from the electrodes (e.g., the
electrode array is moved away from conductive apparatus 4622). A
current is applied to one or more of the leads, and current is
looked for at one or more of the other leads. No current (or only
specific current--more on this below) should be detected because
the hypothetical leads have been removed.
[0241] FIG. 56 presents a hypothetical open circuit scenario, where
lead 12 has experienced a break at the location indicated by the
"X." In an exemplary method, a current is applied by current
generator/detector 1040 to lead 12. Current generator/detector 1040
"looks" for a current at either or both of leads 11 and 13. Because
the conductive apparatus 4622 has placed electrode 2 into
electrical conductivity with electrodes 1 and 3 via hypothetical
leads 1010 and 1030, a current will not register at either of leads
11 and 13 (or only one of the leads if only one of the hypothetical
leads 1010 and 1030 or present) thus indicating that there is an
open circuit, most likely between current generator detector 1040
and electrode 2.
[0242] Note that by "looking" for a current at two or more leads,
it can be immediately deduced that there is a fault between current
generator/detector 1040 and electrode 2 (or a simultaneous fault in
electrodes 1 and 3, which can be addressed by running the test by
applying current at lead 11 and/or lead 13 and looking at lead
12).
[0243] In an exemplary embodiment, a common ground impedance
(voltage required to drive a current between a chosen electrode and
all the other electrodes shorted together) is measured for each
electrode in turn many times a second (1, 2, 3 . . . 22, 1, 2, 3 .
. . 22, 1, 2, 3 . . . 22, etc.). In this way, whatever electrodes
are in contact with the contacts in the sheath, such will show up
as low impedance. As the electrode array advances through the
sheath, the low impedance point will travel down the array from
electrode 22 to electrode 1. An open circuit will be evident as the
electrodes that never go to low impedance.
[0244] Note further that in at least some exemplary methods, the
methods are not executed to detect which lead or which connection
is open or otherwise has experienced a failure mode. A
determination that there is some failure anywhere will typically be
utilitarian in that a determination can be made in view of the
single failure detection that the cochlear implant 100 should not
be implanted in the recipient at that time. In an exemplary
embodiment, a new cochlear implant 100, such as a cochlear implant
100 located in a new apparatus 400, will be obtained, and a new
round of testing for an open circuit will be executed. Such is also
the case with respect to detecting which particular electrodes are
associated with a short circuit.
[0245] Note that by way of example only and not by way of
limitation, in an exemplary embodiment, a failure mode can
correspond to a break in a lead and/or a disconnect between a lead
and an electrode, which failure mode can typically result in an
open circuit. In an exemplary embodiment, this can occur during
shipping of the apparatus 400.
[0246] It is further noted that in an exemplary embodiment, instead
of a solid or contiguous conductive component that contacts the
various electrodes, separate contacts 2262 supported by conductive
body that extends between the contacts can be configured to be
compressible, at least with respect to the portions on the tip, as
can be seen in FIGS. 57A and 57B. In an exemplary embodiment,
element 4622 is replaced by conductive apparatus 2223.
Alternatively, and/or in addition to this, the contacts 2262 can be
supported on a flexible material that flexes to provide space. The
contact can also be spring loaded in another exemplary embodiment
(more on this below). FIG. 58 depicts another exemplary embodiment
of a conductive apparatus 2224 that can be utilized in place of
element 4622. Also, in this exemplary embodiment, the conductors
2262 can be located only at the top of the conductive apparatus
2223, instead of all the way around, as is the case with the
embodiment of FIG. 58.
[0247] It is further noted that variations of the concepts depicted
herein can be implemented to enable the teachings detailed herein.
Instead of utilizing triangular contacts as seen, square contacts
can be utilized. Still further, undulating contact surfaces can be
utilized such that the crests of each undulation are in phase with
the respective electrodes (e.g., aligned with the centers of the
electrodes) of the electrode array. FIG. 58 depicts an exemplary
embodiment of a conductive apparatus 2224 utilizing a "wavy"
contact surface, where contact apparatus 2264 can be seen to have
crests that are in phase with the electrodes of the electrode array
145.
[0248] In an exemplary embodiment, any of the teachings of U.S.
patent application Ser. No. 15/164,789, filed on May 26, 2016, to
Inventor Grahame Walling, for testing for an open circuit can be
incorporated into an insertion guide with the requisite
modifications to enable open circuit testing.
[0249] It is noted that any of the aforementioned opened circuit
detection devices and/or the short circuit detection devices can be
placed into signal communication with a control unit and/or a
testing unit according to the system detailed herein that can
receive the data and determine whether or not there exists an open
circuit and/or a short circuit, etc., which data can be utilized to
implement the system detailed herein vis-a-vis the collecting data
for the conditioning methods.
[0250] While the embodiments detailed above have been directed
towards a device that shorts two electrodes, an alternate
embodiment utilizes an electrode in the insertion guide to
establish a capacitive coupling with the electrodes of the
electrode array as the electrodes of the electrode array pass by
the electrode of the insertion guide. FIG. 59 depicts an alternate
embodiment of an electrode array insertion tube having another
functionality beyond that associated with supporting and/or guiding
the electrode array into the cochlea. In this regard, element 5201
is an electrode that is utilized as part of an open circuit testing
system. Here, electrode 5201 can establish a capacitive coupling
between the electrodes in the array and the insertion guide in
general, and the electrode 5201 in particular.
[0251] As can be seen, electrode 5201 is connected to a lead 5210.
In an exemplary embodiment, this lead energizes the electrode with
an electrical current. In an alternate embodiment, this lead
provides a return path in a scenario where the electrodes of the
electrode array are energized. FIG. 60 depicts an exemplary
embodiment of an insertion guide 5300 having the electrode 5301 to
establish the capacitive coupling with the electrodes of the
electrode array. Here, electrode 5301 is located to the left
(proximally) of the stop 204. FIG. 60 depicts a cutout view of the
tube of the insertion guide showing electrode 5301 extending into
the lumen. Lead 5210 can be seen extending from electrode 5301 to a
coupling, to which is connected a lead 53061, which in turn extends
to test unit 5360. Test unit 5360 is configured to energize the
electrode 5301 in at least some exemplary embodiments. In some
alternate embodiments, test unit 5360 is configured to receive
current from electrode 5301 in the case where the electrodes of the
array are energized.
[0252] FIG. 61 depicts electrode 6307 in signal communication with
a lead that leads to connector 6320. In an exemplary embodiment,
connector 6320 is connected to a device that analyzes the output of
lead. All of the connectors disclosed herein can be connected to
the reference electrode(s) of the cochlear implant.
[0253] In an exemplary embodiment, the electrode array insertion
guide provides source currents from the electrodes thereof. In an
exemplary embodiment, the electrode array insertion guide is
configured with a current generator that provides a specific
current at a specific voltage from the electrode(s) of the guide.
In this regard, the electrodes of the electrode array insertion
guide can operate as a source with respect to the teachings of U.S.
patent application Ser. No. 14/843,255. To this end, FIG. 61
depicts an exemplary insertion guide 6500, that provides a current
and voltage generator 6520, which is in communication with
electrode 6307 via an electrical lead extending therefrom. In an
exemplary embodiment, the generator 6520 can also be in
communication with the other electrodes of the electrode array
insertion guide. In an exemplary embodiment, the generator 6520
includes relays and/or transistors and/or switching components that
enable the generator to alternately switch delivery of current from
one electrode to the other electrode. In this regard, in an
exemplary embodiment, the generator 6520 can have the functionality
and/or the structure of the components of the receiver/stimulator
of the cochlear implant of U.S. patent application Ser. No.
14/843,255 with respect to generating a source current from the
electrodes of the electrode array, when implementing the teachings
of that patent application. In an exemplary embodiment, the
generator 6520 can be a battery that is connected to circuitry that
outputs a stable current at a stable voltage. In an exemplary
embodiment, the generator 6520 can be adjustable so as to output
different currents at different voltages. Consistent with the
teachings detailed herein, the guide 6500 can have a switch or the
like to allow the surgeon to activate and/or deactivate the current
generator 6520. Alternatively, and/or in addition to this, the
guide 6500 can be configured so as to allow selective energizement
and/or deenergizement of the electrodes of the guide. While some
embodiments permit such as part of the handheld guide, in some
alternate embodiments, the guide is configured to be placed into
communication with a control unit. For example, as seen in FIG. 62,
guide 6500 can be equipped with a connector 6320 in signal
communication with the voltage/current generator 6520. The
connector can be connected to a connector 6207 that is connected to
a control unit 6650, which can be a personal computer or the like.
In an exemplary embodiment, the control unit 6650 can control the
output of the current generator 6520 with respect to the current,
the voltage, and which electrodes are operated as the source. Note
further that in some exemplary embodiments, the voltage/current
generator 6520 is not part of the guide 6500, but instead is part
of the control unit 6650. Indeed, in such an exemplary embodiment,
there can be separate leads from each electrode that extend to the
connector 6320. It is noted that the electrode can be also located
on the outside of the cochlea in some other embodiments, consistent
with the teachings detailed above.
[0254] It is noted that in an exemplary embodiment, the control
unit 6650 is the implant itself. In an exemplary embodiment, it is
the receiver-stimulator unit of a cochlear implant, alone in some
embodiments, or when placed into inductance communication with an
external component or a component that replicates the functionality
of the external component, etc. It is noted that the electrodes can
be used as read electrodes, consistent with the teachings detailed
herein, and thus the electrodes can be used as reference electrodes
when the lead connects to the implant (e.g., can or hard ball).
[0255] By way of example only and not by way of limitation, a lead
from the guide, such as the lead leading from connector 6207, could
clip onto the existing extra cochlear electrode (sometimes referred
to as the hardball) of the implant, allowing the implant to look
for open circuits, measure voltages, etc., through the electrode on
the guide. In this regard, in an exemplary embodiment, the
electrodes of the insertion guide can become an extension of the
extra cochlear electrode. Accordingly, an embodiment exists where
any functionality of the cochlear implant that relies on the extra
cochlear electrode can thus also rely on the electrodes of the
insertion guide to achieve such functionality. Corollary to this is
that in an exemplary embodiment, any of the functions detailed
herein that utilize the electrodes of the insertion guide can be
executed by the implants in at least some exemplary embodiments
when the implant is in signal communication with the implant, or at
least when the insertion guide is connected to the extra cochlear
electrode of the electrode array.
[0256] Still, in at least some exemplary embodiments, the guide
6500 can be configured so that the surgeon or the like can toggle
from one electrode to another. For example, the guide can be
provided with a switch or a button that the surgeon depresses to
selectively energize a given electrode. The electrodes can be
energized in sequence by repeatedly pressing the button. In an
exemplary embodiment, an indicator on the guide can be provided so
as to convey information to the surgeon as to which electrode is
being operated as the source. By way of example only and not by way
of limitation, an array of LEDs can be arrayed about the insertion
stop 204. As a given electrode is energized, the LEDs can light.
The LED at the 9 o'clock position could indicate that the closest
electrode to the stop has been energized (e.g., electrode 6307).
The LED at the 3 o'clock position (when viewing the stop 204 from
the surgeon point of view) could indicate that the furthest
electrode to the stop has been energized (e.g., electrode 6302).
The electrodes in between can correspond to LEDs in between the 9
o'clock position in the 3 o'clock position. Alternatively, LEDs
having different colors can be utilized to indicate to the surgeon
which electrode is being utilized as a source. The LEDs can be
utilized according the teachings detailed herein to disclose, for
example, the indicator of an anomalous electrode position. Such is
also the case with respect to LCDs or the like when so
utilized.
[0257] FIG. 63 depicts an alternate embodiment of the electrode
array insertion guide, insertion guide 6700, that is utilized as a
sink and/or read electrode. Here, a lead extends from electrode
6307 to a connector 6320. Other leads also extend in a similar
manner, but are not shown. In an exemplary embodiment, connector
6320 can be hooked up to or otherwise connected to a unit that will
receive the signal from the electrodes when used as a sink and/or a
read electrode By way of example only and not by way of limitation,
in an exemplary embodiment, a test unit can be a personal computer
in signal communication with connector 6320. The personal computer
can analyze the output from connector 6320 indicative of the
current/voltage at electrode 6307 or any other electrode of the
electrode array insertion guide. That said, in an exemplary
embodiment, the guide 6700 can be placed into signal communication
with the receiver/stimulator of the cochlear implant, and the
cochlear implant can be configured to utilize the electrodes of the
insertion guide as the reference electrodes and/or stimulation
electrodes. That is, this is also that this is the case with
respect to embodiments where the electrodes of the electrode array
insertion guide are utilized as the source. That is, connector 6320
can allow the insertion guide to be placed into signal
communication with the receiver/stimulator of the cochlear implant,
and the cochlear implant can be configured to utilize the
electrodes of the insertion guide as the source electrode.
[0258] Note also that in an exemplary embodiment, whether the guide
is utilized as a source or a sink for the current, and/or the read
electrode(s) the insertion guide 6700 can be configured to be
placed into signal communication with any ancillary equipment
utilized in the teachings of the '255 application so as to
implement the teachings thereof where the electrodes of the
insertion guide are the source or the sink.
[0259] Any arrangement of the insertion guide that can enable
electrodes thereof to operate as a source or a sink instead of
utilizing the electrodes of the electrode array as the respective
source or a sink when implementing the teachings of the '255 patent
application can be utilized in at least some exemplary embodiments.
Thus, in an exemplary embodiment, the guide is configured to
interface with any of the components detailed in the '255 patent
application to enable such.
[0260] As noted above, the insertion guide can incorporate visual
indicators to provide intraoperative feedback to the surgeon. As
detailed above, exemplary embodiments have LEDs or the like arrayed
about the stop. Still further, in an exemplary embodiment, a liquid
crystal display or the like can be incorporated in or on the
insertion guide. In this regard, FIG. 64 depicts an exemplary
embodiment of an insertion guide 7300 which includes LCD 7410
mounted on the insertion guide tube. LCD 7410 is in electrical
communication with other components of the guide and/or other
systems remote from the guide via electrical lead 7406. In an
exemplary embodiment, the LCD can provide text and/or numerical
data to the surgeon during implantation/insertion of the electrode
array. The LCD or the other visual indicators can be located
anywhere on the guide that will be within the surgeon's immediate
field-of-view, but also where the indicator will not obstruct the
surgeon's field-of-view of the pertinent portions of the anatomy of
the recipient and/or the pertinent portions of the guide 7300
during insertion of the electrode array. In an exemplary
embodiment, the indicators provide information pertaining to
insertion depth, which can include the absolute depth and/or an
indication that the electrode array has reached the intended or
programmed stopped depth. Indication can be an insertion speed,
which can be absolute speed of insertion or can be an indication
that the insertion speed limit has been exceeded. The indication
can be an adverse measurement indication. This measurement can be a
general indication, such as an indicator that something has gone
wrong whatever that is, or specific indication, such as an
indication explicitly relating to tip fold over, basilar membrane
contact, scala dislocation, etc. Accordingly, in an exemplary
embodiment, such indication can correspond to any of the anomalous
electrode position indicators detailed herein.
[0261] As noted above, embodiments include an insertion guide
configured to communicate with a receiver/stimulator of a cochlear
implant. In this regard, FIG. 65 depicts an exemplary insertion
guide 7400 which is presented by way of concept. Insertion guide
7400 is a functional component FC mounted thereon. This functional
component is representative of any of the additional
functionalities of the insertion guide detailed herein and/or
variations thereof. For example, element FC could be an electrode,
it could be the acoustic stimulation generator, or it could be the
ultrasonic transducer. FC could also be any of the indicators
detailed herein (e.g., the LCD screen). As can be seen, insertion
guide 7400 includes connector 64705 in electrical communication
with the functional component FC via electrical lead 746. Connector
64705 is connected to connector 7407 of inductance coil 7444. In an
exemplary embodiment, inductance coil 7444 includes coil 7410
configured to establish a magnetic inductance field so as to
communicate with the corresponding coil of the receiver-stimulator
of the cochlear implant. Inductance coil 7444 includes a magnet
7474 so as to hold the inductance coil 7474 against the coil of the
receiver/stimulator of the cochlear implant in a manner analogous
to how the external component of the cochlear implant is held
against the implanted component, and how the coils of those
respective components are aligned with one another. While the
embodiment depicted in FIG. 65 depicts no other functional
component between the functional component FC and the inductance
coil 7444, in an alternate embodiment, one or more of the units
detailed herein can be located there between. By way of example,
generator 6520 with respect to the insertion guide 6500 detailed
above can be located therebetween or otherwise be in signal
communication with the leads so as to establish communication with
that element with the cochlear implant. In an exemplary embodiment,
a communications unit or the like is located between or otherwise
is in signal communication with the leads so as to establish
communication with the cochlear implant receiver-stimulator. In an
exemplary embodiment, the insertion guide includes logic or a
processor or other type of control unit that enables the insertion
guide to work in conjunction with the cochlear implant so as to
execute any of the methods detailed herein, such as, for example,
where one or more electrodes of the electrode array insertion guide
are utilized in a state of one or more electrodes of the electrode
array as taught in those applications.
[0262] FIG. 65 also shows second lead from connector 7407 extending
to alligator clip 7474, which in an exemplary embodiment,
configured to clip onto the hard ball and/or the can of the
implant, in which clip is in electrical communication with one or
more electrodes on the electrode array that would be inside and/or
outside of the cochlea during insertion. Indeed, it is also noted
that in an exemplary embodiment, the entire portion that is
inserted into the cochlea of the insertion guide can be the
electrode, and thus be in electrical communication with the
alligator clip 7474.
[0263] It is noted that at least some exemplary embodiments include
utilization of the insertion guides detailed herein and/or
variations thereof with a robotic electrode array insertion system.
In this regard, FIG. 66 is a perspective view of an exemplary
embodiment of an insertion system 400. It is noted that the
embodiment depicted in FIG. 66 is presented for conceptual purposes
only. Features are provided typically in the singular show as to
demonstrate the concept associated therewith. However, it is noted
that in some exemplary embodiments, some of these features are
duplicated, triplicated, quadplicated, etc. so as to enable the
teachings detailed herein and/or variations thereof. Briefly, it is
noted that any teaching detailed herein can be combined with a
robotic apparatus and/or a robotic system according to the
teachings detailed herein and/or variations thereof. In this
regard, any method action detailed herein corresponds to a
disclosure of a method action executed by a robotic apparatus
and/or utilizing a robot to execute that action and/or executing
that method action is part of a method where other actions are
executed by robot and/or a robotic system etc. Still further, it is
noted that any apparatus detailed herein can be utilized in
conjunction with a robotic apparatus and/or a robot and/or a system
utilizing such. Accordingly, any disclosure herein of an apparatus
corresponds to a disclosure of an apparatus that is part of a
robotic apparatus and or a robotic system etc. and or a system that
includes a robotic apparatus etc.
[0264] System 400 includes a robotic insertion apparatus including
arm 7510 to which insertion guide 200 or any other insertion guide
according to the teachings detailed herein and/or variations
thereof is attached (e.g., bolted to arm 7510). In this exemplary
embodiment, arm 7510 is depicted as a single structure extending
from the insertion guide to mount 7512. However, in an alternate
embodiment, arm 7510 can be a multifaceted component which is
configured to articulate at various locations thereabout.
[0265] In an exemplary embodiment, arm 7510 is releasably connected
by way of a releasable connection to mount 7512, which is supported
by a support and movement system 420, comprising support arm 422
which is connected to joint 426 which in turn is connected to
support arm 424. Support arm 424 is rigidly mounted to a wall, a
floor, or some other relatively stationary surface. That said, in
an alternative embodiment, support arm 424 is mounted to a frame
that is attached to the head of the recipient or otherwise
connected to the head of the recipient such that global movement of
the head will result in no relative movement of the system 400 in
general, and the insertion guide in particular, relative to the
cochlea. Joint 426 permits arm 2510, and thus the insertion guide,
to be moved in one, two, three, four, five, or six degrees of
freedom. (It is noted again that FIG. 66 is but a conceptual
FIG.--there can be joints located along the length of arm 7510, so
as to enable arm 75102 articulate in the one or more the
aforementioned degrees of freedom at those locations. In an
exemplary embodiment, joint 426 includes actuators that move mount
7512, and thus the insertion guide, in an automated manner, as will
be described below. In an exemplary embodiment, the system is
configured to be remotely controlled via communication with a
remote control unit via communication lines of cable 430. In an
exemplary embodiment, the system is configured to be automatically
controlled via a control unit that is part of the system 400.
Additional details of this will be described below.
[0266] The system 400 further includes by way of example only and
not by way of limitation, sensor/sensing unit 432. That said, in
some embodiments, sensor 432 is not part of system 400. In some
embodiments, it is a separate system. Still further, in some
embodiments, it is not utilized at all with system 400. While
sensor 432 is depicted as being co-located simultaneously with the
insertion guide, etc., as detailed below, sensor 432 may be used
relatively much prior to use of the insertion guide. Sensing unit
432 is configured to scan the head of a recipient and obtain data
indicative of spatial locations of internal organs (e.g., mastoid
bone 221, middle ear cavity 423 and/or ossicles 106, etc.) In an
exemplary embodiment, sensing unit 432 is a unit that is also
configured to obtain data indicative of spatial locations of at
least some components of the insertion guide and/or other
components of the robotic apparatus attached thereto. The obtained
data may be communicated to remote control unit 440 via
communication lines of cable 434. As may be seen, sensor 432 is
mounted to a support and movement system 420 that may be similar to
or the same as that used by the robotic apparatus supporting the
insertion guide.
[0267] In an exemplary embodiment, sensing unit 432 is an MRI
system, an X-Ray system, an ultrasound system, a CAT scan system,
or any other system which will permit the data indicative of the
spatial locations to be determined as detailed herein and/or
variations thereof. As will be described below, this data may be
obtained prior to surgery and/or during surgery. It is noted that
in some embodiments, at least some portions of the insertion guide
are configured to be better imaged or otherwise detected by sensing
unit 432. In an exemplary embodiment, the tip of the insertion
guide includes radio-opaque contrast material. The stop of the
insertion guide can also include such radio-opaque contrast
material. In an exemplary embodiment, at least some portions of
insertion guide in general, and the robotic system in particular,
or at least the arm 7510, mount 7512, arm 422, etc., are made of
non-ferromagnetic material or other materials that are more
compatible with an MRI system or another sensing unit utilized with
the embodiment of FIG. 66 than ferromagnetic material or the like.
As will be described in greater detail below, the data obtained by
sensing unit 432 is used to construct a 3D or 4D model of the
recipient's head and/or specific organs of the recipient's head
(e.g., temporal bone) and/or portions of the robotic apparatus of
which the insertion guide is a part. That said, to be clear, in
some embodiments, sensing unit 432 is not present, as seen in FIG.
67.
[0268] It is also noted that in some exemplary embodiments of
system 400, there are actuators or the like that drive the
electrode array through the insertion guide into the cochlea. These
actuators can be in signal communication with the control unit. In
an exemplary embodiment, the control unit can control the actuators
to push the electrode array into and/or out of the cochlea as will
be described in greater detail below. Concomitant with the robotic
assembly supporting the insertion guide, in an exemplary
embodiment, the control unit is configured to automatically control
these actuators.
[0269] FIG. 68 is a simplified block diagram of an exemplary
embodiment of a remote control unit 440 for controlling the robotic
apparatus supporting the insertion guide and sensing unit 432 via
communication lines 430 and 434, respectively. Again, it is noted
that in some alternate embodiments, the remote control unit 440 is
an entirely automated unit. That said, in some alternate
embodiments, the remote control unit can be operated automatically
as well as manually, which details will be described below.
[0270] Remote control unit 440 includes a display 442 that displays
a virtual image of the mastoid bone obtained from sensor 432 and
may superimpose a virtual image of the insertion apparatus onto the
virtual image indicative of a current position of the drill bit
relative to the ear anatomy. An operator (e.g., surgeon, certified
healthcare provider, etc) utilizes remote control unit 440 to
control some or all aspects of the robotic apparatus and/or sensing
unit 432. Exemplary control may include depth of insertion guide
insertion, angle of guide insertion, speed of advancement and/or
retraction of electrode array, etc. Such control may be exercised
via joystick 450 mounted on extension 452 which fixedly mounts
joystick 450 to a control unit housing. Such control may be further
exercised via joystick 460 which is not rigidly connected to
housing of remote control unit 440. Instead, it is freely movable
relative thereto and is in communication with the remote control
unit via communication lines of cable 462. Joystick 462 may be part
of a virtual system in which the remote control unit 440
extrapolates control commands based on how the joystick 462 is
moved in space, or joystick may be a device that permits the
operator more limited control over the cavity borer 410. Such
control may include, for example an emergency stop upon release of
trigger 464 and/or directing the robot to drive the insertion guide
further into the cochlea by squeezing the trigger 464 (which, in
some embodiments, may control a speed at which the insertion guide
is advanced by squeezing harder and/or more on the trigger). In the
same vein, trigger 454 of joystick 450 may have similar and/or the
same functionality.
[0271] Control of the robot assembly supporting the insertion guide
may also be exercised via knobs 440 which may be used to adjust an
angle of the insertion guide in the X, Y and Z axis, respectively.
Other controls components may be included in remote control
440.
[0272] FIG. 68 depicts an exemplary insertion guide which can
correspond to any of the insertion guide detailed herein and/or
variations thereof, or any other insertion guide for that matter,
further including an electrode array insertion actuator 7720. In an
exemplary embodiment, actuator assembly 7720 includes a passageway
therethrough through which the electrode array extends. The
actuator assembly drives the electrode array in a manner
replicating that by which the surgeon pushes the electrode array
forward along the insertion guide and into the insertion tube and
thus into the cochlea.
[0273] FIG. 69 depicts an exemplary embodiment of the actuator
assembly 7720. As can be seen, actuator assembly includes two
actuators 7824 in the form of wheels mounted to electric motors
that rotate the wheels in a counterclockwise direction so as to
advance the electrode array, and in a clockwise direction so as to
retract the electrode array. Actuator assembly 7720 further
includes a floor 7822. The floor 7822 works in combination with the
actuators 7824 so as to "trap" the electrode array there between
with a sufficiently compressive force so that the friction forces
between the actuators 7824 and the electrode array enable the
actuators 7824 to drive the electrode array forward and/or
backwards, but not enough so as to damage the electrode array. FIG.
70 depicts an exemplary movement of the wheels 7824.
[0274] FIG. 71 functionally depicts an electrode array 145 "loaded"
in actuator assembly 7720 prior to driving the electrode array into
the insertion sheath. FIG. 72 functionally depicts the electrode
array being driven forward (FIG. 72 is depicted in a functional
manner--in reality, the electrode array 145 would extend up the
ramp and then into the insertion sheath), and FIG. 73 functionally
depicts the electrode array being retracted from the position seen
in FIG. 72.
[0275] While the embodiment of the actuator assembly depicted in
FIG. 71 includes two top actuators, in an alternate embodiment,
only one top actuator is utilized and/or in another embodiment,
three or four or five or six or more actuators are utilized. Also,
in an exemplary embodiment, one or more bottom actuators can also
be utilized. Note also that instead of the actuators being located
on the top and the floor 7822 being on the bottom, the actuators
can be located on the bottom and the floor can be located on the
top.
[0276] It is noted that while the embodiment of FIG. 71 is depicted
utilizing actuators having round wheels, in an alternate
embodiment, other types of working and of the actuators can be
utilized
[0277] To be clear, the embodiment of FIG. 68 depicted above can
also include the actuator assembly's detailed herein and/or
variations thereof. That is, insertion guide 7700 can be attached
to the arm 7510 of the system 400. Moreover, the actuators of the
actuator assembly can be placed into signal communication with the
control unit 440 or any other control unit of the system 400 to
enable the control unit to advance and/or retract the electrode
array. Note also that in some alternate embodiments, the system 400
is such that the only non-manually actuating component is the
actuator assembly. That is, in an exemplary embodiment, system 400
can be such that the frame of the like is placed around the
recipient's head and secured thereto, and the arm 7510 supporting
the insertion guide attached thereto can be moved manually by the
surgeon, such that the surgeon can align or otherwise place the
insertion guide into the cochlea. In this regard, by way of example
only and not by way of limitation, the insertion guide can be
configured so as to attached to the arm 7510 on a trolley or the
like. In an exemplary embodiment, the surgeon moves arm 7510 into
position so that the insertion guide is aligned with the cochlea,
at the desired angle, etc., and then be surgeon manually pushes the
insertion guide forward into the cochlea (in the case of an
intra-cochlear insertion guide) or against the cochlea in the case
of a non-intra-cochlea insertion guide). After that, the actuator
assembly can be utilized in a remote-controlled and/or automated
manner.
[0278] That said, in an alternate embodiment, the general positions
of the system 400 can be established utilizing manual methods, and
then the positions can be refined utilizing automated/remote
controlled methods (e.g., the actuators on the arm 7510 and/or the
actuator at joint 426 can be actuated so as to finally position the
insertion guide.
[0279] Note also that in some exemplary embodiments, the actuator
assembly's detailed herein and/or variations thereof that are
utilized to advance and/or retract the electrode array are
configured to be utilized with an insertion tool that is handheld
instead of being attached to arm 750 system 400. To this end, FIG.
74 depicts an exemplary insertion tool 8200 that includes actuator
apparatus 7720 as seen. Hereinafter, the reference will often be
made to actuator apparatus 7720 as utilized in conjunction with
other components detailed herein. Any disclosure herein of the
utilization of actuator apparatus 7720 in conjunction with other
teachings detailed herein corresponds to a disclosure of the
utilization of the actuator apparatus 8123 or any of the other
actuator apparatuses detailed herein or variations thereof utilized
to grip and support and/or insert the electrode array into the
cochlea. FIG. 74 depicts a connector 67405 in signal communication
with an actuator apparatus 7720, which connector is connected to
connector 7407, which in turn is connected to a lead which extends
to the control unit. In an exemplary embodiment, the surgeon holds
the tool 8200 in the traditional manner of use, but the control
unit controls the actuation of the actuator 7720 to advance and/or
retract the electrode array. In an exemplary embodiment, the
surgeon or other healthcare professional can exercise override
control over the insertion of the electrode array and/or the
retraction of the electrode array. For example, switching
components of the like or other types of input devices can be
located on the tool 8200 so that the surgeon or the like can
provide input into the system of which the tool 8200 is a part. In
an alternate embodiment, the tool 8200 can include an input device
that interacts with the surgeon, where the surgeon provides the
direction to the system advance and/or retract the electrode array,
but the control unit evaluates the inputs from the surgeon and
controls the actuation accordingly. By way of example only and not
by way of limitation, such a system can be analogous to a fly by
wire system on an aircraft, where the pilot moves the controls in a
manner correlated to the direction that the pilot wants the
aircraft to move, and the flight control system controls everything
else to achieve the desired outcome. Note also that any the other
actuators detailed herein and/or variations thereof can be part of
a system that is operated in a similar manner. By way of example
only and not by way of limitation, the system 400 can be configured
such that the surgeon pushes on the arm 7510 to move the insertion
guide is desired, but the system 400 moves the arm 7510 using
actuators. That is, the system 400 is configured to sense or
otherwise detect the force is applied on to the structure thereof
by the surgeon, and then determine what actuator action should be
executed so as to position the insertion guide at the desired
location in a manner analogous to fly by wire.
[0280] It is noted that the electrical lead assembly and the
connectors thereof depicted in FIG. 74 can be applicable to any of
the insertion guides detailed herein and/or variations thereof so
as to place the insertion guide in general, and the actuator
assembly thereof in particular, into signal communication with the
control unit or other controllers of the system. Note also that in
an exemplary embodiment, the lead apparatus depicted in FIG. 74 can
be utilized to also convey the other signals detailed herein and/or
variations thereof with respect to the other functionalities
associated with the insertion guides. Alternatively, and/or in
addition to this, the other lead apparatuses detailed herein and
variations thereof can be utilized to convey the signals from the
actuator apparatus 7720 to the control unit or the like when the
insertion guides detailed above are utilized in conjunction with
the actuator assembly so as to provide a machine drive to advance
and/or retract the electrode array. Any device, system and/or
method of communication between any functional component of any of
the insertion guides detailed herein and/or variations thereof with
a control unit and/or vice versa and/or the implantable component
of the electrode array, etc., can be utilized in at least some
exemplary embodiments
[0281] It is also noted that while the embodiments detailed herein
have been directed towards an electrode array guide, it is also
noted that in some alternate embodiments, an electrode array
support is instead utilized, which support may not necessarily
guide the electrode array, but otherwise might simply support the
electrode array proximate to the cochlea. Note that in an electrode
array support can also be an electrode array guide, and vice
versa.
[0282] In view of the above, it can be understood that in an
exemplary embodiment, there is an apparatus, such as any of the
insertion guides detailed herein and/or variations thereof, that
includes an electrode array support, and an actuator. In at least
some of these exemplary embodiments, the apparatus is configured to
inserts an electrode array into cochlea by a controlled actuation
of the actuator. In an exemplary embodiment of such an exemplary
embodiment, the controlled actuation is at least partially based on
electrical phenomenon of the recipient. Some additional details of
such will now be described.
[0283] FIG. 75 depicts an exemplary functional schematic of an
exemplary system that includes the test unit 3960 detailed above in
signal communication with a control unit 8310 which is in turn in
signal communication with the actuator assembly 7720. The test unit
and the control unit can be one and the same in some
embodiments.
[0284] It is also noted that in some embodiments, the there is no
control unit and/or there is no actuator assembly. That is, the
system can be a purely test system, which conveys information to
the surgeon or other healthcare professional to instruct (e.g., the
output of the control unit and/or the test unit can be instead an
instruction as opposed to a control signal) or otherwise provide an
indication of the phenomenon to the surgeon or other healthcare
professional.
[0285] Also functionally depicted in FIG. 75 is the optional
embodiment where an input device 8320 is included in the system
(e.g., which could be on an embodiment where the actuator assembly
7720 is part of a hand tool or where actuator assembly 7720 is part
of an insertion guide, where the input device 8320 is located
remote from the insertion guide, which could be part of a remote
unit 440). In an exemplary embodiment, the input device 8320 could
be the trigger for 54 and/or 464 of the remote control unit 440. In
an exemplary embodiment, the input device 8320 could be a trigger
on the tool 8200. Again, in an exemplary embodiment, the input
device 8320 can be utilized to enable advancement and/or withdrawal
of the electrode array, and the system 400 could control the
advancement and/or withdrawal based on an automated protocol or
some other flyby wire type system. In the embodiment of FIG. 75,
the input device 8320 can be in signal communication directly to
the actuator assembly 7720, and/or in signal communication with the
control unit 8310.
[0286] In an exemplary embodiment, control unit 8310 can correspond
to the remote unit 440. That said, in an alternate embodiment,
remote unit 440 can be a device that is in signal communication
with control unit 8310. Indeed, in an exemplary embodiment, input
device 8320 can correspond to remote control unit 440.
[0287] More particularly, control unit 8310 can be a signal
processor or the like or a personal computer or the like or a
mainframe computer or the like etc., that is configured to receive
signals from the test unit 3960 and analyze those signals to
evaluate an insertion status of the electrode array. More
particularly, the control unit 8310 can be configured with software
the like to analyze the signals from test unit 3960 in real time
and/or in near real time as the electrode array is being advanced
into the cochlea by actuator assembly 7720. The control unit 8310
analyzes the input from test unit 3960 as the electrode array
advanced by the actuator assembly 7720 and evaluates the input to
determine if there exists an undesirable insertion status of the
electrode array and/or evaluates the input to determine if the
input indicates that a scenario could occur or otherwise there
exists data in the input that indicates that a scenario is more
likely to occur relative to other instances where the insertion
status of the electrode array will become undesirable if the
electrode array is continued to be advanced into the cochlea, all
other things remaining the same (e.g., insertion angle/trajectory,
etc., which can be automatically changed as well via--more on this
below). In an exemplary embodiment, upon such a determination,
control unit 8310 could halt the advancement of the array into the
cochlea by stopping the actuator(s) of actuator assembly 7720
and/or could slow the actuator(s) so as to slow rate of advancement
of the electrode array into the cochlea and/or could reverse the
actuator(s) so as to reverse or otherwise retract the electrode
array within the cochlea (either partially or fully). In at least
some exemplary embodiments, control unit 8310 can be configured to
override the input from input unit 8320 input by the surgeon or the
user or the like of the systems herein.
[0288] In an exemplary embodiment, the outputs of test unit 3960
corresponds to the outputs indicated herein. Alternatively and/or
in addition to this, input into control unit 8310 can flow from
other sources. Any input relating to the measurement of voltage
associated executing the teachings herein into control unit 8310
can be utilized in at least some exemplary embodiments.
[0289] In an exemplary embodiment, control unit 8310 can be
configured to determine, based on the input from test unit 3960,
whether the electrode array has come into contact with the basilar
membrane of the cochlea and/or that one or more of the anomalous
electrode positions has occurred and/or whether there exists an
increased likelihood that such will occur, and automatically
control the actuator assembly 7720 accordingly. In an exemplary
embodiment, control unit 8310 does not necessarily determine that
such an insertion status exists or is more likely to exist, but
instead is programmed or otherwise configured so as to control the
actuator assembly 7720 according to a predetermined regime based on
the input from the test unit 3960. That is, the control unit 8310
need not necessarily "understand" otherwise "know" the actual
insertion status or the forecasted insertion status of the
electrode array, but instead need only be able to control the
actuator assembly 7720 based on the input.
[0290] In an exemplary embodiment, control unit 8310 can be
configured to determine, based on the input from test unit 3960,
the insertion depth of the electrode array and/or a forecasted
insertion depth of the electrode array, and automatically control
the actuator assembly 7720 accordingly. In an exemplary embodiment,
control unit 8310 does not necessarily determine the insertion
depth or forecasted insertion depth, but instead is programmed or
otherwise configured so as to control the actuator assembly 7720
according to a predetermined regime based on the input from the
test unit 3960. That is, the control unit 8310 need not necessarily
"understand" otherwise "know" the actual insertion depth or the
forecasted insertion depth of the electrode array, but instead need
only be able to control the actuator assembly 7720 based on the
input.
[0291] In an exemplary embodiment, control unit 8310 can be
configured to determine, based on the input from test unit 3960,
executing, for example, the methods/techniques disclosed herein,
whether the electrode array has buckled and/or bent and/or any
other anomalous electrode location as disclosed herein or otherwise
may be the case and/or whether there exists an increased likelihood
that such will occur, and automatically control the actuator
assembly 7720 accordingly. In an exemplary embodiment, control unit
8310 does not necessarily determine that such buckling and/or
bending exists or is more likely to exist, but instead is
programmed or otherwise configured so as to control the actuator
assembly 7720 according to a predetermined regime based on the
input from the test unit 3960. That is, the control unit 8310 need
not necessarily "understand" otherwise "know" that the electrode
array has actually buckled or will buckle in the future, but
instead need only be able to control the actuator assembly 7720
based on the input.
[0292] Thus, it can be understood that there is an apparatus that
is configured to receive input indicative of the electrical
phenomenon/phenomena inside the recipient, and develop data
indicative of a position of the electrode array within the cochlea
based on the input. (It is briefly noted that unless otherwise
specified, the singular term phenomenon also includes a disclosure
of the plural thereof, and vis-a-versa, as is also the case with
the disclosure of data). Still further, such an exemplary
embodiment can be configured to adjust the control of the actuation
of the actuator based on the develop data indicative of the
position of the electrode array.
[0293] To be clear, while the embodiment detailed above is focused
on controlling the actuator assembly 7720 based on data from the
system so as to control the advancement and/or retraction of the
electrode array based on the data disclosed herein and, in an
alternate embodiment, the system 400 controls one or more other
actuators of the robot apparatus of system 400. These one or more
other actuators can be exclusive from the actuator assembly 7720,
or can include the actuator assembly 7720. In this regard, FIG. 76
depicts an exemplary robot apparatus 8400, that includes the
insertion guide 3900 detailed above with respect to the integration
of a system ad disclosed herein therewith mounted on arm 8424
utilizing bolts in a manner concomitant with that detailed above.
In an exemplary embodiment, robot apparatus 8400 has the
functionality or otherwise corresponds to that of the embodiment of
FIG. 68. In this regard, any functionality associated or otherwise
described with respect to the embodiment of FIG. 68 corresponds to
that of the embodiment of FIG. 76, and vice versa. In this
exemplary embodiment, the actuator apparatus 7720 is in signal
communication with unit 3810 via electrical lead 84123. In this
regard, signals to and/or from the actuator assembly 7720 can be
transmitted to/from the antenna of unit 8310 (in FIG. 84, the "Y"
shaped elements are antennas) and thus communicated via lead 84123.
It is briefly noted that while the embodiment depicted in FIG. 76
utilizes radiofrequency communication, in alternate embodiments,
the communications can be wired. In an exemplary embodiment both
can be utilized.
[0294] The robot apparatus 8400 includes a recipient interface 8410
which entails an arch or halo like structure made out of metal or
the like that extends about the recipient's cranium or other parts
of the body. The interface 8410 is bolted to the recipient's head
via bolts 8412. That said, in alternate embodiments, other regimes
of attachment can be utilized, such as by way of example only and
not by way of limitation, strapping the robot to the recipient's
head. In this regard, the body and interface 8410 can be a flexible
strapping can be tightened about the recipient's head.
[0295] Housing 8414 is located on top of the interface 8410, as can
be seen. In an exemplary embodiment, housing 8414 includes a
battery or the like or otherwise provides an interface to a
commercial/utility power supply so as to power the robot apparatus.
Still further, in an exemplary embodiment, housing 8414 can include
hydraulic components/connectors to the extent that the actuators
herein utilize hydraulics as opposed to and/or in addition to
electrical motors. Mounted on housing 8414 is the first actuator
8420, to which arm 8422 is connected in an exemplary embodiment,
actuator 8420 enables the components "downstream" (i.e., the arm
connected to the actuator, and the other components to the
insertion guide) to articulate in one, two, three, four, five or
six degrees of freedom. A second actuator 8420 is attached to the
opposite end of the arm 8422, to which is attached a second arm
8422, to which is attached a third actuator 8420, to which is
attached to the insertion guide attachment structure 8424. Elements
8422 and 8424 can be metal beams, such as I beams or C beams or box
beams, etc. actuators 8420 can be electrical actuators and/or
hydraulic actuators.
[0296] As can be seen, each actuator 8420 is provided with an
antenna, which antenna is in signal communication with the control
unit 8310. In an exemplary embodiment, control unit 8310 can
control the actuation of those actuators 8420 so as to position the
insertion guide 3900 at the desired position relative to the
recipient. That said, in an alternate embodiment, a single antenna
can be utilized, such as one mounted on housing 8414, which in turn
is connected to a decoding device that outputs a control signal,
such as a driver signal based on the decoded RF signal, to the
actuators 8420 (as opposed to each actuator having such a device),
which control signals can be provided via a wired system/electrical
leads extending from housing 8414 to the actuators. Note also that
in some alternate embodiments, control unit 8310 is in wired
communication with the actuators, either directly or indirectly,
and/or is in wired communication with the decoding device located
in the housing 8414. Any arrangement that can enable control of the
robot apparatus in general, and the actuators thereof in
particular, via control unit 8310 can be utilized in at least some
exemplary embodiments.
[0297] Note also that while the embodiment depicted in FIG. 76 is
such that the actuators 8420 must actuate so as to extend the
intracochlear portion of the insertion guide into the cochlea, in
an alternate embodiment, as noted above, the insertion guide can be
mounted on a rail system or the like, wherein a cylindrical
actuator or the like pushes the insertion guide in a linear manner
into the cochlea and withdrawals the insertion guide in the linear
manner from the cochlea. In an exemplary embodiment, this actuator
apparatus can enable one degree of freedom movements of the
insertion guide, while in other embodiments, this actuator
apparatus can enable two or three or four or five or six degrees of
freedom. Indeed, in an exemplary embodiment, this actuator
apparatus can enable movement only in a linear direction, but can
enable rotation of the insertion guide about the longitudinal axis
thereof. Any arrangement of actuator assemblies that will enable
the insertion guide to be positioned relative to the cochlea and/or
inserted into the cochlea via robotic positioning thereof can be
utilized in at least some exemplary embodiments.
[0298] Any control unit and/or test unit or the like disclosed
herein can be a personal computer programs was to execute one or
more or all of the functionalities associated there with are the
other functionalities disclosed herein. In an exemplary embodiment,
any control unit and/or test unit or the like can be a dedicated
circuit assembly configured so as to execute one or more or all of
the functionalities associated there with or the other
functionalities disclosed therein. In an exemplary embodiment, and
the control unit and/or test unit or the like disclosed herein can
be a processor or the like or otherwise can be a programmed
processor.
[0299] FIG. 77 depicts another exemplary embodiment, as seen. FIG.
77 presents such an exemplary embodiment, with the links between
the antennas removed for clarity. Testing system 4044 detailed
shown in signal communication with control unit 8310. In this
exemplary embodiment, system 4044 corresponds to that detailed
above vis-a-vis determining anomalous electrode location with the
exception that it is entirely divorced from the insertion guide,
save for the communication between system 4044 and the control unit
8310, to the extent such is relevant for the purposes of
discussion, where control unit 8310 is in signal communication with
one or more of the assemblies of the robot apparatus, such as the
actuator assembly 7720. Here, during insertion, and/or prior to
insertion and/or after insertion, the system 4044 monitors or
otherwise measures electrical phenomenon detailed herein and
communicates those measurements and/or the analysis thereof to
control unit 8310, which analyzes those signals and develops a
control regime for electrode array insertion and/or electrode array
positioning based on those signals. Note also that in some
exemplary embodiments, the system 4044 can have multiple
measurement electrodes and/or signal generators/sources of acoustic
signal generation, some of which are part of the robot apparatus,
and some of which are separate from the robot apparatus, all of
which are part of system 4044. Alternatively, these various
components of the system 4044 can communicate with test unit 3960.
Such can have utilitarian value with respect to a scenario where
measurements are first taken prior to placing the electrode array
near the cochlea and after inserting the electrode array into the
cochlea, where it is undesirable to have the insertion guide and/or
electrode array support proximate the cochlea. Any device, system,
and/or method that will enable controlled movement of the electrode
array relative to the cochlea based on electrical phenomenon
associated with the recipient/based on electrical characteristics
associated with the recipient can be utilized in at least some
exemplary embodiments.
[0300] Again, the test unit and the system 4044 can be one and the
same in some embodiments, and in some embodiments, functionality
can be bifurcated between the two as separate units. Indeed, 4044
in FIG. 77 can be a proxy for the control unit and/or the test
units detailed above.
[0301] In view of the above, it can be seen that some embodiments
provide for the automatic detection of a fold over array, a
dislocation, bowing or buckling, or other phenomenon, in patients
with cochlear implants in an objective manner, and such can provide
an automated method for identifying the affected area. Again, the
teachings herein can be executed without or in addition to medical
imaging tests (e.g. CT scan, X-ray, etc.), or otherwise requiring
the recipient/patient to be exposed to radiation during the process
of obtaining medical images, and/or subsequent analysis by an
expert to assess the correct insertion of the electrode holder
and/or measuring neuronal activation after stimulation. In some
embodiments, the teachings herein can be executed with methods to
attempt to detect neural activation, and can still provide the
above reliability in a scenario where there is no neuronal response
due to several causes not related to the orientation of the
array.
[0302] In view of the above, it can be seen that in an exemplary
embodiment, there is a methodology for detecting one or more
fold-overs of a patient's electrode holder, which can include a
method and device for obtaining the values of the electric
potential produced by the activation of one evaluation electrode
with respect to all others, obtaining an activation level (in some
implementations defined in coulombs) of the electrode of the
electrode holder under evaluation, in some embodiments, the other
electrodes on the electrode holder store the electrical potential
value of each electrode while the electrode holder under evaluation
is stimulated. In an exemplary method, the potentials obtained are
organised in a data array structure, where the rows represent the
stimulated electrode and the columns represent the potential
perceived at each electrode, or vice versa. The existence of one or
more secondary diagonals of the array can be detected and verified.
In some implementations, the secondary diagonal can be detected by:
[0303] Standard deviation; [0304] Search for positive slopes in
potential; [0305] Search for a change of slope in potential; [0306]
Peak location; [0307] Search for positive slopes in potential;
[0308] Search for a change of slope in potential;
[0309] In the event of having a secondary diagonal, the occurrence
of a fold-over can be verified and the crossing between the primary
diagonal (where in some embodiments the primary diagonal is that
where the electrode that is stimulated and the one that perceives
the potential are the same) and the secondary one is defined as the
point or points of fold-over.
[0310] In an exemplary embodiment of this method, it is possible to
determine after the insertion of the electrode holder (array)
whether or not there is a fold-over and if it exists, on which
electrode or electrodes the fold-over has occurred. Basically,
obtaining the measurements of the potential using the electrodes of
the electrode holder and the processing of these potential
measurements allows to obtain as a result the existence or
non-existence of the Fold-Over and in which electrode or electrodes
it occurs.
[0311] In some examples, the method may further comprise the action
of conditioning the potential measurements, this conditioning step
being configured to reduce the noise of these measurements,
detection of defective electrodes and scaling and normalised
measurements at the interval [0,1] prior to the process stage. To
this end, this conditioning step may comprise one or more filtering
elements of the electrical potential measurements. Where any of the
implementations of these filters could be: [0312] Median filter;
[0313] Mean filter; [0314] Adaptive filter;
[0315] According to some examples, the electrical stimulus entails
a monopolar two-phase pulse and the potential measurement is
obtained at the end of the first phase of the stimulus. In this
way, the potential obtained can be a maximum.
[0316] In some examples, the matrix data structure may degenerate
into a vector when a single electrode is evaluated with regard to
the rest of the electrodes. Thus the value of the electrical
potential in all electrodes is not necessarily recorded when one of
them is under evaluation.
[0317] The above-mentioned computer programme may be stored in
physical storage media, such as recording media, computer memory,
or read-only memory, or may be carried by a carrier wave, such as
electrical or optical.
[0318] As seen above, a computer system is described which may
comprise a memory and a processor, instructions are stored in the
memory which can be executed by the processor and these
instructions comprise functionalities to execute a procedure to
detect if a fold-over has occurred and on which Electrode it has
occurred, as described above.
[0319] An exemplary embodiment includes an array organized as
follows: [0320] Evaluated electrodes are found in the columns of
the array. [0321] The rows of the array are made up of the
electrodes that have recorded the potential. [0322] In each of the
array cells the potential value is recorded.
[0323] Therefore, for example, field [10,3] of the array stores the
value of the potential recorded by electrode number 10 while
electrode number 3 was being activated. At this point it is noted
that the potentials array may comprise different numbers of
electrodes depending on the electrode holder guide used.
[0324] In an exemplary embodiment, there is a method that include
the action of obtaining potentials array, the action of
conditioning the potential measurements obtained. Filtering actions
can be executed by utilizing any of the following: [0325] Median
filter; [0326] Mean filter; [0327] Adaptive filter;
[0328] Another action includes, the detection in the electrode
holder such as short circuits, open circuit, bubbles or other
problems not related to the Fold-Over, and the action of, where the
presence of a second diagonal is detected, where any of the
implementations could be: [0329] Standard deviation; [0330] Search
for positive slopes in potential; [0331] Search for a change of
slope in potential; [0332] Peak location; [0333] Search for
positive slopes in potential; [0334] Search for a change of slope
in potential;
[0335] Another action includes calculating the electrode on which
the fold-over pivots is calculated in the event a fold-over has
been detected in the previous action.
[0336] At this point it is noted that a method for detecting
fold-overs may comprise different configurations at the stage
level. Thus, as described above, in these examples the
configuration is based on the use of an array data structure.
[0337] In an exemplary embodiment, there is a method for detecting
a fold-over in cochlear implant electrode holders characterised by
an action for obtaining the values of the electric potential
produced by the activation of an evaluation electrode with respect
to all others, to which potentials are organised in an array data
structure, where the stimulated electrode is represented in the
rows, and the perceived potential at each electrode is represented
in the columns, or vice versa, an action for detecting and
verifying the existence of one or more secondary diagonals of the
array. In the event of having a secondary array, the occurrence of
a fold-over is verified and the crossing between the primary and
secondary diagonal is defined as the point or points of
fold-over.
[0338] In view of the above, there is a device for executing one or
more of the method detailed above, including the ability to define
an activation value of an evaluation electrode at a level of
activation (in some implementations defined in Coulombs) defined by
the user to record the potential generated by the electrode, inside
the cochlea. In view of the above, there is a device for executing
one or more of the method detailed above, including the ability to
obtain electrical potential values in one or more electrodes housed
in the electrode holder which may include the evaluation electrode
itself. In view of the above, there is a device for executing one
or more of the method detailed above, including the ability to
average potential measurements at each measuring electrode.
[0339] In an exemplary embodiment of the methods detailed above,
the values of the potentials are organised into an array data
structure which can degenerate into a vector data structure. In an
exemplary embodiment, there is the action of applying a filtering
step to improve the quality of the data comprising a filter, such
as: [0340] Median filter; [0341] Mean filter; [0342] Adaptive
filter;
[0343] In an exemplary embodiment of the methods detailed above,
there is the ability to exclude electrodes with other types of
errors such as air bubbles, short circuits and open circuits when
searching for fold-overs. In an exemplary embodiment of the methods
detailed above, wherein the existence of one or more secondary
diagonals of the value of the obtained potential is identified. In
an exemplary embodiment of the methods detailed above, there is one
or more executions of a search for a secondary diagonal, using the
following schemes: [0344] Standard deviation; [0345] Search for
positive slopes in potential; [0346] Search for change of slope in
potential;
[0347] In an exemplary embodiment of the methods detailed above,
wherein the existence of one or more secondary diagonal is
executed, when the structure containing the potential values has
degenerated to a vector, as for example: [0348] Peak location;
[0349] Search for positive slopes in potential; [0350] Search for a
change of slope in potential;
[0351] In an exemplary embodiment of the methods detailed above,
there is a search for the intersection between the primary diagonal
and any of the secondary ones indicating the electrode on which the
fold-over occurs. Also, there is a computer program comprising
computer instructions to cause a computer system to execute a
method according to any of the teachings herein to detect an
anomalous condition. There can also be a computer system comprising
a memory and a processor, with instructions stored on its memory
which can be executed by the processor and such instructions
comprising functionalities for executing a method according to any
of that disclosed herein, in full or in part, for detecting a
fold-over or a dislocation or any other anomalous electrode
location of a cochlear implant.
[0352] In some embodiments, there are a plurality of electrodes
that include at least one electrode configured to record the
voltage produced by the electrode under evaluation.
[0353] In an exemplary embodiment, there is a method,
comprising:
[0354] obtaining information indicative of a phenomenon sensed at,
at least one read electrode relative to at least one reference of a
cochlear implant electrode array and/or at a read electrode remote
from the electrode array relative to a reference where at least one
of the electrodes of the cochlear implant electrode array was
energized;
[0355] executing a first analysis of the information to identify
one or more first meanings from among a first group of meanings of
the sensed phenomenon;
[0356] conditioning the obtained information based on the
identified one or more first meanings; and
[0357] executing a second analysis of the conditioned information
to identify one or more second meanings from among a second group
of meanings of the sensed phenomenon.
[0358] In an exemplary embodiment, there is a method as described
above and/or below, wherein the one or more first meanings
corresponds to an electrical phenomenon that at least one of will
not change or will change with time without further movement of the
electrode array in the cochlea, all other things being equal.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0359] providing a virtual indication to a healthcare professional
that a fold over of the electrode array has occurred and the
location thereof based on the second analysis.
In an exemplary embodiment, there is a method, comprising:
[0360] commencing insertion of a cochlear electrode array into a
cochlea of a person;
[0361] establishing a source and sink of electrical current in the
recipient, wherein the source is one of an energized stimulation
electrode of the electrode array that is located inside the cochlea
or an energized electrode remote from the electrode array;
[0362] reading at least one read electrode, relative to at least
one reference, that received an electrical signal from the
energized stimulation electrode; and
[0363] determining, based on the reading, that a physical
characteristic associated with the electrode array that is strictly
local to the electrode array existed and/or exists.
In an exemplary embodiment, there is a method as described above
and/or below, wherein the physical characteristic is a temporally
dynamic characteristic related to the physical condition of the
electrode array. In an exemplary embodiment, there is a method as
described above and/or below, wherein:
[0364] after the determining action, adjusting a location of the
electrode array in the cochlea and executing a second reading of
the read electrode/s or of at least one other read electrode of the
electrode array; and
[0365] determining, based on the second reading, that the physical
characteristic is a first characteristic as opposed to a second
characteristic because the second reading, after the movement, is
effectively different than the reading.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0366] after the determining action, adjusting a location of the
electrode array in the cochlea and executing a second reading of
the read electrode/s relative to a reference or of at least one
other read electrode of the electrode array relative to a
reference; and
[0367] determining, based on the second reading, that the physical
characteristic is a second characteristic as opposed to a first
characteristic because the second reading, after the movement, is
effectively the same as the reading.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0368] after the determining action, adjusting a location of the
electrode array in the cochlea and executing a second reading of
the read electrode/s relative to a reference or of another read
electrode of the electrode array, relative to a reference; and
[0369] determining, based on the second reading, that the physical
characteristic associated with the electrode array no longer
exists.
In an exemplary embodiment, there is a method as described above
and/or below, wherein, further comprising:
[0370] after the determining action, adjusting a location of the
electrode array in the cochlea and executing a second reading of
the read electrode/s relative to a reference or of another read
electrode of the electrode array, relative to a reference; and
[0371] determining, based on the second reading, that the physical
characteristic associated with the electrode array no longer
exists.
In an exemplary embodiment, there is a method as described above
and/or below, wherein
[0372] the physical characteristic is a temporally static
characteristic related to the physical condition of the electrode
array, and wherein the method further comprising:
[0373] second energizing at least one stimulation electrode of the
electrode array that is located inside the cochlea or an electrode
remote from the electrode array;
[0374] second reading at least one read electrode relative to at
least one reference that received an electrical signal from the
energized stimulation electrode, wherein the read electrode/s is
part of the electrode array if the energized stimulation electrode
is an electrode remote from the electrode array; and
[0375] confirming the prior determination, based on the second
reading, that the physical characteristic associated with the
electrode array that is strictly local to the electrode array
existed and/or exists.
In an exemplary embodiment, there is a method, comprising:
[0376] (i) obtaining information indicative of a phenomenon sensed
at, at least one read electrode relative to at least one reference
of a cochlear implant electrode array; and
[0377] (ii) using that information to determine whether or not a
deleterious cochlear electrode array position exists inside the
cochlea of a recipient, wherein
[0378] the actions used to make the determination correspond to a
statistical based accuracy rating of at least 90 out of 100
vis-a-vis determinations that a deleterious cochlear electrode
array position exists.
In an exemplary embodiment, there is a method as described above
and/or below, wherein:
[0379] action "ii" includes first conditioning the obtained
information and then analyzing the conditioned information to make
the determination.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0380] after conditioning the information or prior to conditioning
the information, and prior to analyzing, normalizing the
information and then analyzing the normalized conditioned
information or the conditioned normalized information to make the
determination.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0381] reanalyzing the information without the normalizing or
analyzing the information before normalizing to make a second
determination as to whether or not another type of deleterious
cochlear electrode array position exists inside the cochlea of the
recipient.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0382] executing a normalizing action on the information
conditioned according to the second type prior to analyzing such;
and
[0383] not executing a normalizing action on the information
conditioned according to the first type prior to analyzing
such.
In an exemplary embodiment, there is a method as described above
and/or below, further comprising:
[0384] after action "i," determining whether or not to execute a
conditioning action on the obtained information and/or what type of
conditioning action is to be executed on the obtained information;
and
[0385] normalizing the information before or after executing the
conditioning action, if executed, and analyzing the normalized
information to make the determination.
In an exemplary embodiment, there is a method as described above
and/or below, wherein:
[0386] the result of the action of determining what type of
conditioning action is a determination to execute a type of
conditioning action that is conducive to determining whether or not
dislocation has occurred; and
[0387] the method further includes determining not to normalize the
information.
[0388] Any disclosure of any method action detailed herein
corresponds to a disclosure of a device and/or a system for
executing that method action. Any disclosure of any method of
making an apparatus detailed herein corresponds to a resulting
apparatus made by that method. Any functionality of any apparatus
detailed herein corresponds to a method having a method action
associated with that functionality. Any disclosure of any apparatus
and/or system detailed herein corresponds to a method of utilizing
that apparatus and/or system. Any feature of any embodiment
detailed herein can be combined with any other feature of any other
embodiment detailed herein providing that the art enables such,
unless such is otherwise noted.
[0389] Any disclosure herein of a method of making a device herein
corresponds to a disclosure of the resulting device. Any disclosure
herein of a device corresponds to a disclosure of making such a
device.
[0390] Any one or more elements or features disclosed herein can be
specifically excluded from use with one or more or all of the other
features disclosed herein.
[0391] While various embodiments of the present invention have been
described above, it should be understood that they have been
presented by way of example only, and not limitation. It will be
apparent to persons skilled in the relevant art that various
changes in form and detail can be made therein without departing
from the scope of the invention.
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